title: Corrigendum to Council Directive 1999/38/EC of 29 April 1999 amending for the second time Directive 90/394/EEC on the protection of workers from the risks related to exposure to carcinogens at work and extending it to mutagens (OJ L 138 of 1.6.1999)

text:
12. 2. 2000          EN                           Official Journal of the European Communities                                           L 37/35
                                                                    CORRIGENDA
            Corrigendum to Commission Regulation (EC) No 238/2000 of 28 January 2000 amending Regulation (EC) No
            1222/94 laying down common detailed rules for the application of the system of granting export refunds on
            certain agricultural products exported in the form of goods not covered by Annex I to the Treaty, and the
                                                 criteria for fixing the amount of such refunds
                                     (Official Journal of the European Communities L 24 of 29 January 2000)
            On page 52, in the title of column 3 of the table ‘Record sheet’:
            for:  ‘Amount granted’,
            read: ‘Amount requested’.
            Corrigendum to Council Directive 1999/38/EC of 29 April 1999 amending for the second time Directive
            90/394/EEC on the protection of workers from the risks related to exposure to carcinogens at work and
                                                               extending it to mutagens
                                       (Official Journal of the European Communities L 138 of 1 June 1999)
            On page 68, Article 1(3):
            for:  ‘In Article 1(1), Article 3(1), (2), first and second indents, […] Article 14(3), Article 16(1) and Article 17(2), the
                  word “carcinogens” shall be replaced by “carcinogens or mutagens”;’
            read: ‘In Article 1(1), Article 3(1), (2), first and second subparagraphs, […] Article 14(3) and (8), Article 16(1) Article
                  17(2) and Annex II, point 1, the word “carcinogens” shall be replaced by “carcinogens or mutagens”;’.


title: Corrigendum to Council Directive 93/31/EEC of 14 June 1993 on stands for two-wheel motor vehicles (OJ L 188, 29.7.1993)

text:
               9.7.2004

               EN

               Official Journal of the European Union

               L 239/36

         Corrigendum to Council Directive 93/31/EEC of 14 June 1993 on stands for two-wheel motor vehicles
   (
         Official Journal of the European Communities L 188 of 29 July 1993
      )
   On page 21, in the Annex, point 3.1.1.3.2:
   for:

      ‘

                  3.1.1.3.2.

                  when the vehicle moves forward as a result of deliberate action by the driver following the first contact of the prop stand with the ground;

            ’

   read:

      ‘

                  3.1.1.3.2.

                  when the vehicle moves forward as a result of deliberate action by the driver;

            ’.


Avis juridique important

|

31988L0344R(01)

Corrigendum to Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (OJ L 157 of 24.6.1988)

Official Journal L 032 , 05/02/2004 P. 0034 - 0034

Corrigendum to Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients(Official Journal of the European Communities L 157 of 24 June 1988)On page 29, Article 2(4):for: 4. Water, to which substances regulating acidity or alkalinity may have been added, other food substances which possess solvent properties and ethanol are authorized as extraction solvents in the manufacture of foodstuffs or food ingredients.read: 4. Water, to which substances regulating acidity or alkalinity may have been added, and other food substances which possess solvent properties are authorised as extraction solvents in the manufacture of foodstuffs or food ingredients.


title: COMMISSION DIRECTIVE (EU) .../… amending, for the purpose of adaptation to technical and scientific developments, point 13 of part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards chromium VI

text:
               COMMISSION DIRECTIVE (EU) .../…

               of 16.5.2018

               amending, for the purpose of adaptation to technical and scientific developments, point 13 of part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards chromium VI

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys
                  1
               , and in particular Article 46(1)(b) thereof,

               Whereas:

               (1)Directive 2009/48/EC sets a limit value for chromium VI in scraped-off toy material such as paints on toys, hard and soft polymers, wood, textiles, and others. The current limit value (0,2 mg/kg) is based on a virtually safe dose of 0,0053 µg of chromium VI per kg bodyweight per day proposed by the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency
                  2
               .

               (2)At the request of the European Commission, the Scientific Committee on Health and Environmental Risks (SCHER) assessed in 2015 the relevance of the oral cancer potency of chromium VI. In its opinion on "Chromium VI in toys" adopted on 22 January 2015
                  3
               , SCHER reported to have reviewed, among others, the OEHHA technical support document for the Public Health Goal for chromium VI in drinking water
                  4
                 and a US-National Toxicology Program (NTP) study
                  5
               . The SCHER considered 0,0002 µg of chromium VI per kg bodyweight per day, derived by the OEHHA as being associated with one additional cancer case in a million, as an appropriate  virtually safe dose.

               (3)Since children are also exposed to chromium VI through sources other than toys, only a certain percentage of the virtually safe dose should be taken as the basis when calculating the limit value for chromium VI. The maximum contribution from toys to the daily intake of chromium VI recommended by the Scientific Committee on Toxicity, Ecotoxicity and the Environment in its 2004 opinion
                  6
                is 10 %. This percentage was confirmed twice by the Scientific Committee on Health and Environmental Risks in 2010
                  7
               ,
                  8
               .

               (4)In addition, for chromium VI and other chemical substances which are particularly toxic, Directive 2009/48/EC suggests in its recital 22 to set limit values at half of those considered safe by the relevant Scientific Committee, in order to ensure that only traces that are compatible with good manufacturing practice will be present.

               (5)Applying 10 % of the  virtually safe dose, multiplied by the average weight of a child under three years of age, estimated at 7,5 kg, divided by the daily quantity of scraped-off toy material ingested, estimated at 8 mg/day, and multiplied by ½ led the SCHER to propose, in its above-mentioned opinion on "Chromium VI in toys", 0,0094 mg/kg as a revised limit value for chromium VI in scraped-off toy material.

               (6)Compliance with the proposed limit value can, however, not be verified with the test method in European standard EN 71-3:2013+A1:2014, the reference of which has been published in the Official Journal of the European Union
                  9
               . The proposed limit value is almost six times lower than the lowest concentration that can be reliably quantified with the test method in the standard, which is 0,053 mg/kg.

               (7)In those circumstances, the subgroup "Chemicals" of the Expert Group on Toys Safety established by the Commission
                  10
                recommended at its meeting on 14 October 2016 to lower the limit value for chromium VI from the current 0,2 mg/kg to 0,053 mg/kg. The subgroup "Chemicals" equally recommended to review available test methods for chromium VI every two years to possibly identify a test method that can reliably measure even lower concentrations, until the limit value proposed by SCHER has been reached.

               (8)The European Committee for Standardization (CEN) is currently reviewing the test method in standard EN 71-3 with regard to improving the detection of chromium VI. A revised test method is expected to be available soon allowing to reliably measure concentrations down to 0,0025 mg/kg. It would then be possible to strengthen further the limit value for chromium VI in scraped-off toy material.

               (9)Directive 2009/48/EC should therefore be amended accordingly.

               (10)The measures provided for in this Directive are in accordance with the opinion of the Toy Safety Committee,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               In point 13 of Part III of Annex II to Directive 2009/48/EC, the entry for chromium VI is replaced by the following entry:

                        Element

                        mg/kg

                        in dry, brittle, powder-like or pliable toy material

                        mg/kg

                        in liquid or sticky toy material

                        mg/kg

                        in scraped-off toy material

                        ”Chromium (VI)

                        0,02

                        0,005

                        0,053”

               Article 2

               1.Member States shall adopt and publish, by [18 months after publication in the OJ] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

               They shall apply those provisions from [18 months after publication in the OJ + 1 day].

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

               Article 3

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 16.5.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 170, 30.6.2009, p. 1.

                     (2)

                        OEHHA (1999). Public health goal for chromium in drinking water. Pesticide and Environmental Toxicology Section, Office of Environmental Health Hazard Assessment, California Environmental Protection Agency. Dated February 1999. Cited in: Chemicals in Toys. A general methodology for assessment of chemical safety of toys with a focus on elements RIVM report 320003001/2008. National Institute for Public Health and the Environment (RIVM) of The Netherlands. p. 114, Table 8-1.

                     (3)

                        Scientific Committee on Health and Environmental Risks (SCHER), Opinion on "Chromium VI in toys". Adopted on 22 January 2015.

                  http://ec.europa.eu/health/sites/health/files/scientific_committees/environmental_risks/docs/scher_o_167.pdf

                     (4)

                        OEHHA (2011). Public health goals for chemicals in drinking water. Hexavalent chromium (Cr VI).
                  http://oehha.ca.gov/water/phg/072911Cr6PHG.html

                     (5)

                        National Toxicology Program (2008). Toxicology and Carcinogenesis Studies of Sodium Dichromate Dihydrate (CAS No. 7789-12-0) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP TR 546, NIEHS, Research Triangle Park, NC. NIH Publication No. 08-5887.

                     (6)

                        Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE). Opinion on "Assessment of the bioavailability of certain elements in toys". Adopted on 22 June 2004.

                  http://ec.europa.eu/health/archive/ph_risk/committees/sct/documents/out235_en.pdf

                     (7)

                        Scientific Committee on Health and Environmental Risks (SCHER). Opinion on "Risk from organic CMR substances in toys". Adopted on 18 May 2010.

                     (8)

                        Scientific Committee on Health and Environmental Risks (SCHER). Opinion on "Evaluation of the migration limits for chemical elements in Toys". Adopted on 1 July 2010.

                     (9)

                        OJ C 378, 13.11.2015, p. 1.

                     (10)

                        See Register of Commission Expert Groups, Expert Group on Toys Safety (E01360).

                  http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1360


title: COMMISSION DIRECTIVE (EU) .../… amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms

text:
               COMMISSION DIRECTIVE (EU) .../…

               of 8.3.2018

               amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
                  1
               , and in particular Article 27 thereof,

               Whereas:

               (1)Directive 2001/18/EC of the European Parliament and of the Council sets out requirements for the environmental risk assessment of genetically modified organisms ('GMOs').

               (2)On 4 December 2008, the Council adopted Conclusions on GMOs stressing the need to update and strengthen the environmental risk assessment of GMOs, in particular concerning the assessment of long-term environmental effects.

               (3)Following a request from the Commission, the European Food Safety Authority (EFSA) adopted in October 2010 a Scientific opinion establishing guidance on the environmental risk assessment of genetically modified plants
                  2
                ('the Guidance'), which is a revision of the previous guidance. Other guidance documents issued by EFSA and by the European Medicines Agency are relevant to the environmental risk assessment of GMOs other than plants.

               (4)Article 3 of Directive (EU) 2015/412 of the European Parliament and of the Council
                  3
                provides that by 3 April 2017 the Commission has to update the Annexes to Directive 2001/18/EC as regards the environmental risk assessment with a view to incorporating and building upon the Guidance, which is not legally binding.

               (5)In order to adapt to technical progress and taking into account the experience gained in the environmental risk assessment of genetically modified plants, the essential elements of the Guidance should be incorporated in Directive 2001/18/EC. In doing so, the principle that the environmental risk assessment should be carried out on a case-by-case basis should be respected.

               (6)The Guidance was essentially designed for notifications for the purpose of placing on the market ("Part C notifications") of genetically modified plants, while Annex II to Directive 2001/18/EC applies to both Part C notifications and notifications for other purposes than placing on the market ("Part B notifications"). Therefore, certain requirements resulting from the incorporation of the Guidance in Annex II should only apply to Part C notifications, as they would be irrelevant or disproportionate in the context of Part B notifications, which essentially concern experimental releases.

               (7)Part C of Annex II to Directive 2001/18/EC concerns the methodology of the environmental risk assessment. It should be updated in order to incorporate, in particular, the terminology used to describe the six steps of the assessment approach as described in the Guidance.

               (8)Part D of Annex II to Directive 2001/18/EC applies to the conclusions of the environmental risk assessment and contains two distinct sections, concerning GMOs other than higher plants (section D.1) and genetically modified higher plants (section D.2) respectively. The Guidance considers seven specific areas of risk to be addressed in the environmental risk assessment of genetically modified plants in order to draw conclusions. The structure and content of section D.2 of Annex II should therefore be updated to reflect those areas of risk.

               (9)Where the environmental risk assessment concerns a genetically modified plant made tolerant to a herbicide, its scope should be consistent with Directive 2001/18/EC. The environmental risk assessment of the use of a plant protection product, including its use on a genetically modified plant, falls under the scope of Regulation (EC) No 1107/2009 of the European Parliament and of the Council
                  4
                and will be carried out at Member State level to take into account the specific agricultural conditions.

               (10)Annex III B to Directive 2001/18/EC lists the information required in notifications concerning releases of genetically modified higher plants and applies to both Part C notifications and Part B notifications. Its structure, content and level of detail should be amended to ensure consistency with the Guidance. As most of the changes induced by the Guidance concern the environmental risk assessment of Part C notifications, and in the interest of clarity and simplification for the notifiers and the competent authorities, it is appropriate to modify the structure of Annex III B by separating the requirements concerning Part C notifications from the requirements concerning Part B notifications.

               (11)The majority of the requests for authorisation of the placing on the market of genetically modified plants are submitted in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council
                  5
               . In the interest of simplification, it is therefore appropriate to align, to the extent possible, the order of the pieces of information required for Part C notifications in Annex III B to Directive 2001/18/EC with the order followed in Commission Implementing Regulation (EU) No 503/2013
                  6
               .

               (12)Annex IV to Directive 2001/18/EC sets out additional information requirements only for Part C notifications. The requirements set out in that Annex concerning detection methods should be updated in the light of technical progress, in particular as regards the submission by notifiers of the reference material.

               (13)The measures provided for in this Directive are in accordance with the opinion of the Committee set up under Article 30 of Directive 2001/18/EC,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Annexes II, III, III B and IV to Directive 2001/18/EC are amended in accordance with the Annex to this Directive.

               Article 2

               1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [18 months from the date of entry into force] at the latest. They shall forthwith communicate to the Commission the text of those provisions.

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

               Article 3

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 8.3.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 106, 17.4.2001, p. 1.

                     (2)

                        EFSA Journal 2010;8(11):1879.

                     (3)

                        Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory (OJ L 68, 13.3.2015, p. 1).

                     (4)

                        Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

                     (5)

                        Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).

                     (6)

                        Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (OJ L 157, 8.6.2013, p. 1).

    ---documentbreak---

               ANNEX

               Directive 2001/18/EC is amended as follows:

               (1)Annex II is amended as follows:

               (a)Section C is replaced by the following:

               "C.Methodology

               Guidance issued by the European Food Safety Authority is available for the implementation of this section for Part C notifications.

               C.1.General and specific considerations for the e.r.a.

               1.Intended and unintended changes

               As part of the identification and evaluation of the potential adverse effects referred to in Section A, the e.r.a shall identify the intended and unintended changes resulting from the genetic modification and shall evaluate their potential to cause adverse effects on human health and on the environment.

               Intended changes resulting from the genetic modification are changes that are designed to occur and which fulfil the original objectives of the genetic modification.

               Unintended changes resulting from the genetic modification are consistent changes which go beyond the intended change(s) resulting from the genetic modification.

               Intended and unintended changes can have either direct or indirect, and either immediate or delayed effects on human health and on the environment.

               2.Long-term adverse effects and cumulative long-term adverse effects in the e.r.a. of Part C notifications

               Long-term effects of a GMO are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a GMO or from an extensive use of a GMO in time and space.

               The identification and evaluation of the potential long-term adverse effects of a GMO on human health and on the environment shall take into account the following:

               (a)the long-term interactions of the GMO and the receiving environment;

               (b)the characteristics of the GMO which become important on a long-term basis;

               (c)data obtained from repeated deliberate releases or placings on the market of the GMO over a long period.

               The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introductory part of Annex II shall also take into account the GMOs deliberately released or placed on the market in the past.

               3.Quality of the data

               In order to carry out an e.r.a. for a notification under Part C of this Directive, the notifier shall collate already available data from scientific literature or from other sources, including monitoring reports, and shall generate the necessary data by performing, where possible, appropriate studies. Where applicable, the notifier shall justify in the e.r.a. why generating data by studies is not possible.

               The e.r.a. for notifications under Part B of the Directive shall be based at least on already available data from scientific literature or from other sources and may be supplemented by additional data generated by the notifier.

               Where data generated outside Europe is provided in the e.r.a., its relevance to receiving environment(s) in the Union shall be justified.

               Data provided in the e.r.a for notifications under part C of this Directive shall comply with the following requirements:

               (a)where toxicological studies carried out to assess risk to human or animal health are provided in the e.ra., the notifier shall provide evidence to demonstrate that they were conducted in facilities which comply with:

               (i)the requirements of Directive 2004/10/EC; or

               (ii)the ‘OECD Principles on Good Laboratory Practice’ (GLP), if carried out outside the Union;

               (b)where studies other than toxicological studies are provided in the e.r.a., they shall:

               (i)comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC, where relevant, or

               (ii)be conducted by organisations accredited under the relevant ISO standard, or

               (iii)in the absence of a relevant ISO standard, be conducted in accordance with internationally recognised standards;

               (c)information on the results obtained from the studies referred to in points (a) and (b) and on the study protocols used shall be reliable and comprehensive and shall include the raw data in an electronic format suitable for carrying out statistical or other analysis;

               (d)the notifier shall specify, where possible, the size of effect that each study performed intends to detect and justify it.

               (e)the selection of sites for field studies shall be based on relevant receiving environments in view of the potential exposure and impact that would be observed where the GMO may be released. The selection shall be justified in the e.r.a.;

               (f)the non-genetically modified comparator shall be appropriate for the relevant receiving environment(s) and shall have a genetic background comparable to the GMO. The choice of the comparator shall be justified in the e.r.a.

               4.Stacked transformation events in Part C notifications

               The following shall apply to the e.r.a. of a GMO containing stacked transformation events in Part C notifications:

               (a)the notifier shall provide an e.r.a. for each single transformation event in the GMO or refer to already submitted notifications for those single transformation events;

               (b)the notifier shall provide an assessment of the following aspects:

               (i)the stability of the transformation events;

               (ii)the expression of the transformation events;

               (iii)the potential additive, synergistic or antagonistic effects resulting from the combination of the transformation events;

               (c)where the progeny of the GMO can contain various subcombinations of the stacked transformation events, the notifier shall provide a scientific rationale justifying that there is no need to provide experimental data for the concerned subcombinations, independently of their origin, or, in the absence of such scientific rationale, shall provide the relevant experimental data.

               C.2.Characteristics of the GMO and of the releases

               The e.r.a. shall take into account the relevant technical and scientific details regarding characteristics of:

               –the recipient or parental organism(s);

               –the genetic modification(s), be it insertion or deletion of genetic material, and relevant information on the vector and the donor;

               –the GMO;

               –the intended release or use including its scale;

               –the potential receiving environment(s) into which the GMO will be released and into which the transgene may spread; and

               –the interaction(s) between these characteristics.

               Relevant information from previous releases of the same or similar GMOs and organisms with similar traits and their biotic and abiotic interaction with similar receiving environments, including information resulting from the monitoring of such organisms, shall be considered in the e.r.a, subject to Article 6(3) or Article 13(4).

               C.3.Steps in the e.r.a.

               The e.r.a. referred to in Articles 4, 6, 7 and 13 shall be conducted for each relevant area of risk referred to in Section D1 or in Section D2 in accordance with the following six steps:

               1.Problem formulation including hazard identification:

               The problem formulation shall:

               (a)identify any changes in the characteristics of the organism, linked to the genetic modification, by comparing the characteristics of the GMO with those of the chosen non-genetically modified comparator under corresponding conditions of release or use;

               (b)identify potential adverse effects on human health or the environment which are linked to the changes that have been identified under point (a) above;

               Potential adverse effects shall not be discounted on the basis that they are unlikely to occur.

               Potential adverse effects will vary from case to case, and may include:

               ‒effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations leading to a potential decline in biodiversity;

               ‒altered susceptibility to pathogens facilitating the dissemination of infectious diseases or creating new reservoirs or vectors;

               ‒compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine;

               ‒effects on biogeochemistry (biogeochemical cycles), including carbon and nitrogen recycling through changes in soil decomposition of organic material;

               ‒disease affecting humans, including allergenic or toxic reactions;

               ‒disease affecting animals and plants, including toxic, and, in the case of animals, allergenic reactions, where appropriate;

               Where potential long-term adverse effects of a GMO are identified, they shall be assessed in the form of desk based studies using, where possible, one or more of the following:

               (i)evidence from previous experiences;

               (ii)available data sets or literature;

               (iii)mathematical modelling.

               (c)identify relevant assessment endpoints.

               Those potential adverse effects that could impact the identified assessment endpoints shall be considered in the next steps of the risk assessment.

               (d)identify and describe the exposure pathways or other mechanisms through which adverse effects may occur.

               Adverse effects may occur directly or indirectly through exposure pathways or other mechanisms which may include:

               ‒the spread of the GMO(s) in the environment;

               ‒the transfer of the inserted genetic material to the same organism or other organisms, whether genetically modified or not;

               ‒phenotypic and genetic instability;

               ‒interactions with other organisms;

               ‒changes in management, including, where applicable, in agricultural practices;

               (e)formulate testable hypotheses, and define relevant measurement endpoints, to allow, where possible, a quantitative evaluation of the potential adverse effect(s);

               (f)consider possible uncertainties, including knowledge gaps and methodological limitations.

               2.Hazard characterisation

               The magnitude of each potential adverse effect shall be evaluated. This evaluation shall assume that such an adverse effect will occur. The e.r.a shall consider that the magnitude is likely to be influenced by the receiving environment(s) into which the GMO is intended to be released and by the scale and conditions of the release.

               Where possible, the evaluation shall be expressed in quantitative terms.

               Where the evaluation is expressed in qualitative terms, a categorical description ("high", "moderate", "low" or "negligible") shall be used and an explanation of the scale of effect represented by each category shall be provided.

               3.Exposure characterisation

               The likelihood or probability of each identified potential adverse effect occurring shall be evaluated to provide, where possible, a quantitative assessment of the exposure as a relative measure of probability, or otherwise a qualitative assessment of the exposure. The characteristics of the receiving environment(s) and the scope of the notification shall be taken into consideration.

               Where the evaluation is expressed in qualitative terms, a categorical description ("high", "moderate", "low" or "negligible") of the exposure shall be used and an explanation of the scale of effect represented by each category shall be provided.

               4.Risk characterisation

               The risk shall be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk.

               Where a quantitative or semi quantitative estimation is not possible, a qualitative estimation of the risk shall be provided. In that case, a categorical description ("high", "moderate", "low" or "negligible") of the risk shall be used and an explanation of the scale of effect represented by each category shall be provided.

               Where relevant, the uncertainty for each identified risk shall be described and, where possible, expressed in quantitative terms.

               5.Risk management strategies

               Where risks are identified that require, on the basis of their characterisation, measures to manage them, a risk management strategy shall be proposed.

               The risk management strategies shall be described in terms of reducing the hazard or the exposure, or both, and shall be proportionate to the intended reduction of the risk, the scale and conditions of the release and the levels of uncertainty identified in the e.r.a.

               The consequent reduction in overall risk shall be quantified where possible.

               6.Overall risk evaluation and conclusions

               A qualitative and, where possible, quantitative evaluation of the overall risk of the GMO shall be made taking into account the results of the risk characterisation, the proposed risk management strategies and the associated levels of uncertainty.

               The overall risk evaluation shall include, where applicable, the risk management strategies proposed for each identified risk.

               The overall risk evaluation and conclusions shall also propose specific requirements for the monitoring plan of the GMO and, where appropriate, the monitoring of the efficacy of the proposed risk management measures.

               For notifications under Part C of the Directive, the overall risk evaluation shall also include an explanation of the assumptions made during the e.r.a. and of the nature and magnitude of uncertainties associated with the risks, and a justification of the risk management measures proposed."

               (b)The title and the introductory paragraph of Section D are replaced by the following:

               "D.Conclusions on the specific areas of risk of the e.r.a.

               Conclusions on the potential environmental impact in relevant receiving environments from the release or the placing on the market of GMOs shall be drawn for each relevant area of risk listed in Section D1 for GMOs other than higher plants or Section D2 for genetically modified higher plants, on the basis of an e.r.a. carried out in accordance with the principles outlined in Section B and following the methodology described in Section C, and on the basis of the information required pursuant to Annex III."

               (c)Section D.2. is replaced by the following:

               "D.2.In the case of genetically modified higher plants (GMHP)

               ‘Higher plants’ shall mean plants which belong to the taxonomic group Spermatophytae (Gymnospermae and Angiospermae).

               1.Persistence and invasiveness of the GMHP, including plant to plant gene transfer

               2.Plant to micro-organisms gene transfer

               3.Interactions of the GMHP with target organisms

               4.Interactions of the GMHP with non-target organisms

               5.Impacts of the specific cultivation, management and harvesting techniques

               6.Effects on biogeochemical processes

               7.Effects on human and animal health."

               (2)Annex III is replaced by the following:

               "ANNEX III

               INFORMATION REQUIRED IN THE NOTIFICATION

               Notifications referred to in Parts B and C of this Directive shall, as a rule, include the information set out in Annex III A, for GMOs other than higher plants, or in Annex III B, for genetically modified higher plants.

               The provision of a given subset of information listed in Annex III A or in Annex III B shall not be required where it is not relevant or necessary for the purposes of risk assessment in the context of a specific notification, in view especially of the characteristics of the GMO, of the scale and conditions of the release or of its intended conditions of use.

               The appropriate level of detail for each subset of information may also vary according to the nature and the scale of the proposed release.

               For each required subset of information, the following shall be provided:

               (i)the summaries and results of the studies referred to in the notification, including an explanation about their relevance to e.r.a., where applicable;

               (ii)for notifications referred to in Part C of this Directive, Annexes with detailed information on those studies, including a description of the methods and materials used or the reference to standardised or internationally recognised methods and the name of the body or bodies responsible for carrying out the studies.

               Future developments in genetic modification may necessitate adapting this Annex to technical progress or developing guidance notes on this Annex. Further differentiation of information requirements for different types of GMOs, for example perennial plants and trees, single celled organisms, fish or insects, or for particular use of GMOs like the development of vaccines, may be possible once sufficient experience with notifications for the release of particular GMOs has been gained in the Union."

               (3)Annex III B is replaced by the following:

               "ANNEX III B

               INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND ANGIOSPERMAE)

               I.INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND 7

               A.GENERAL INFORMATION

               1.Name and address of the notifier (company or institute)

               2.Name, qualifications and experience of the responsible scientist(s)

               3.Title of the project

               4.Information relating to the release

               (a)Purpose of the release

               (b)Foreseen date(s) and duration of the release

               (c)Method by which the GMHP will be released

               (d)Method for preparing and managing the release site, prior to, during and post release, including cultivation practices and harvesting methods

               (e)Approximate number of plants (or plants per m2).

               5.Information relating to the site of release

               (a)Location and size of the release site(s).

               (b)Description of the release site ecosystem, including climate, flora and fauna.

               (c)Presence of sexually compatible wild relatives or cultivated plant species.

               (d)Proximity to officially recognised biotopes or protected areas which may be affected.

               B.SCIENTIFIC INFORMATION

               1.Information relating to the recipient plant or, where appropriate, to the parental plants

               (a)Complete name:

               (i)family name

               (ii)genus

               (iii)species

               (iv)subspecies

               (v)cultivar or breeding line

               (vi)common name.

               (b)Geographical distribution and cultivation of the plant within the Union.

               (c)Information concerning reproduction:

               (i)mode(s) of reproduction

               (ii)specific factors affecting reproduction, if any

               (iii)generation time.

               (d)Sexual compatibility with other cultivated or wild plant species, including the distribution in Europe of the compatible species.

               (e)Survivability:

               (i)ability to form structures for survival or dormancy

               (ii)specific factors affecting survivability, if any.

               (f)Dissemination:

               (i)ways and extent of dissemination

               (ii)specific factors affecting dissemination, if any.

               (g)Where a plant species is not normally grown in the Union, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

               (h)Potential interactions of the plant, that are relevant to the GMHP, with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

               2.Molecular characterisation

               (a)Information relating to the genetic modification

               (i)Description of the methods used for the genetic modification.

               (ii)Nature and source of the vector used.

               (iii)Source of the nucleic acid(s) used for transformation, size, and intended function of each constituent fragment of the region intended for insertion.

               (b)Information relating to the GMHP

               (i)General description of the trait(s) and characteristics which have been introduced or modified.

               (ii)Information on the sequences actually inserted/deleted:

               ‒size and copy number of all insert(s) and methods used for its/their characterisation;

               ‒in case of deletion, size and function of the deleted region(s);

               ‒subcellular location(s) of the insert(s) in the plant cells (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its/their determination.

               (iii)Parts of the plant where the insert is expressed.

               (iv)Genetic stability of the insert and phenotypic stability of the GMHP.

               (c)Conclusions of the molecular characterisation

               3.Information on specific areas of risk

               (a)Any change to the persistence or invasiveness of the GMHP, and its ability to transfer genetic material to sexually compatible relatives and the adverse environmental effects thereof.

               (b)Any change to the ability of the GMHP to transfer genetic material to microorganisms and the adverse environmental effects thereof.

               (c)Mechanism of interaction between the GMHP and target organisms (if applicable) and the adverse environmental effects thereof.

               (d)Potential changes in the interactions of the GMHP with non-target organisms resulting from the genetic modification and the adverse environmental effects thereof.

               (e)Potential changes in agricultural practices and management of the GMHP resulting from the genetic modification and the adverse environmental effects thereof.

               (f)Potential interactions with the abiotic environment and the adverse environmental effects thereof.

               (g)Information on any toxic, allergenic or other harmful effects on human and animal health arising from the genetic modification.

               (h)Conclusions on the specific areas of risk.

               4.Information on control, monitoring, post-release and waste treatment plans

               (a)Any measures taken, including:

               (i)spatial and temporal isolation from sexually compatible plant species, both wild and weedy relatives and crops

               (ii)any measures to minimise or prevent the dispersal of any reproductive part of the GMHP.

               (b)Description of methods for post-release treatment of the site.

               (c)Description of post-release treatment methods for the genetically modified plant material including wastes.

               (d)Description of monitoring plans and techniques.

               (e)Description of any emergency plans.

               (f)Description of the methods and procedures to:

               (i)avoid or minimise the spread of the GMHPs beyond the site of release;

               (ii)protect the site from intrusion by unauthorised individuals;

               (iii)prevent other organisms from entering the site or minimise such entries.

               5.Description of detection and identification techniques for the GMHP.

               6.Information about previous releases of the GMHP, if applicable.

               II.INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLE 13

               A.GENERAL INFORMATION

               1.Name and address of the notifier (company or institute).

               2.Name, qualifications and experience of the responsible scientist(s).

               3.Designation and specification of the GMHP.

               4.Scope of the notification.

               (a)Cultivation

               (b)Other uses (to be specified in the notification).

               B.SCIENTIFIC INFORMATION

               1.Information relating to the recipient plant or, where appropriate, to the parental plants

               (a)Complete name:

               (i)family name

               (ii)genus

               (iii)species

               (iv)subspecies

               (v)cultivar/breeding line

               (vi)common name.

               (b)Geographical distribution and cultivation of the plant within the Union.

               (c)Information concerning reproduction:

               (i)mode(s) of reproduction

               (ii)specific factors affecting reproduction, if any

               (iii)generation time.

               (d)Sexual compatibility with other cultivated or wild plant species, including the distribution in the Union of the compatible species.

               (e)Survivability:

               (i)ability to form structures for survival or dormancy

               (ii)specific factors affecting survivability, if any.

               (f)Dissemination:

               (i)ways and extent of dissemination;

               (ii)specific factors affecting dissemination, if any.

               (g)Where a plant species is not normally grown in the Union, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

               (h)Potential interactions of the plant, that are relevant to the GMHP, with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

               2.Molecular characterisation

               (a)Information relating to the genetic modification

               (i)Description of the methods used for the genetic modification.

               (ii)Nature and source of the vector used.

               (iii)Source of the nucleic acid(s) used for transformation, size, and intended function of each constituent fragment of the region intended for insertion.

               (b)Information relating to the genetically modified plant

               (i)Description of the trait(s) and characteristics which have been introduced or modified.

               (ii)Information on the sequences actually inserted or deleted:

               ‒size and copy number of all detectable inserts, both partial and complete, and methods used for its characterisation;

               ‒the organisation and sequence of the inserted genetic material at each insertion site in a standardised electronic format;

               ‒in case of deletion, size and function of the deleted region(s);

               ‒subcellular location(s) of the insert(s) (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its/their determination;

               ‒in the case of modifications other than insertion or deletion, function of the modified genetic material before and after the modification, as well as direct changes in expression of genes as a result of the modification;

               ‒sequence information in a standardised electronic format for both 5’ and 3’ flanking regions at each insertion site;

               ‒bioinformatic analysis using up-to-date databases, to investigate possible interruptions of known genes;

               ‒all Open Reading Frames, (hereafter referred to as ‘ORFs’) within the insert (either due to rearrangement or not) and those created as a result of the genetic modification at the junction sites with genomic DNA. ORF is defined as a nucleotide sequence that contains a string of codons that is uninterrupted by the presence of a stop codon in the same reading frame;

               ‒bioinformatic analysis using up-to-date databases, to investigate possible similarities between the ORFs and known genes which may have adverse effects;

               ‒primary structure (amino acid sequence) and, if necessary, other structures, of the newly expressed protein;

               ‒bioinformatic analysis using up-to-date databases, to investigate possible sequence homologies and, if necessary, structural similarities between the newly expressed protein and known proteins or peptides which may have adverse effects.

               (iii)Information on the expression of the insert:

               ‒method(s) used for expression analysis together with their performance characteristics;

               ‒information on the developmental expression of the insert during the lifecycle of the plant;

               ‒parts of the plant where the insert/modified sequence are expressed;

               ‒potential unintended expression of new ORFs identified under the seventh indent of point (ii), which raise a safety concern;

               ‒protein expression data, including the raw data, obtained from field studies and related to the conditions in which the crop is grown.

               (iv)Genetic stability of the insert and phenotypic stability of the GMHP.

               (c)Conclusions of molecular characterisation

               3.Comparative analysis of agronomic and phenotypic characteristics and of composition

               (a)Choice of conventional counterpart and additional comparators.

               (b)Choice of sites for field studies.

               (c)Experimental design and statistical analysis of data from field trials for comparative analysis:

               (i)Description of field studies design

               (ii)Description of relevant aspect of the receiving environments

               (iii)Statistical analysis

               (d)Selection of plant material for analysis, if relevant.

               (e)Comparative analysis of agronomic and phenotypic characteristics.

               (f)Comparative analysis of composition, if relevant.

               (g)Conclusions of comparative analysis.

               4.Specific information for each area of risk

               For each of the seven areas of risk referred to in Section D.2 of Annex II the notifier shall first describe the pathway to harm explaining in a chain of cause and effect how the release of the GMHP could lead to harm, taking into account both hazard and exposure.

               The notifier shall submit the following information, except where it is not relevant in view of the intended uses of the GMO:

               (a)Persistence and invasiveness including plant to plant gene transfer

               (i)Assessment of the potential for the GMHP to become more persistent or invasive and the adverse environmental effects thereof;

               (ii)Assessment of the potential for the GMHP to transmit transgene(s) to sexually compatible relatives and the adverse environmental effects thereof;

               (iii)Conclusions on the adverse environmental effect(s) of persistence and invasiveness of the GMHP including the adverse environmental effect(s) of plant-to-plant gene transfer.

               (b)Plant to micro-organism gene transfer

               (i)Assessment of the potential for transfer of newly inserted DNA from the GMHP to microorganisms and the adverse effects thereof;

               (ii)Conclusions on the adverse effect(s) of the transfer of newly inserted DNA from the GMHP to microorganisms for human and animal health and the environment;

               (c)Interactions of the GMHP with target organisms, if relevant

               (i)Assessment of the potential for changes in the direct and indirect interactions between the GMHP and target organisms and the adverse environmental effect(s);

               (ii)Assessment of the potential for evolution of resistance of the target organism to the expressed protein (based on the history of evolution of resistance to conventional pesticides or transgenic plants expressing similar traits) and any adverse environmental effect(s) thereof;

               (iii)Conclusions on adverse environmental effect(s) of interactions of the GMHP with target organisms.

               (d)Interactions of the GMHP with non-target organisms.

               (i)Assessment of the potential for direct and indirect interactions of the GMHP with non-target organisms, including protected species, and the adverse effect(s) thereof.

               The assessment shall also take into account the potential adverse effect(s) on relevant ecosystem services and on the species providing those services.

               (ii)Conclusions on adverse environmental effect(s) of interactions of the GMHP with non-target organisms.

               (e)Impacts of the specific cultivation, management and harvesting techniques

               (i)For GMHPs for cultivation, assessment of the changes in the specific cultivation, management and harvesting techniques used for the GMHP and the adverse environmental effect(s) thereof;

               (ii)Conclusions on adverse environmental effect(s) of the specific cultivation, management and harvesting techniques.

               (f)Effects on biogeochemical processes

               (i)Assessment of the changes in the biogeochemical processes within the area in which the GMHP is to be grown and in the wider environment, and the adverse effects thereof;

               (ii)Conclusions on adverse effects on biogeochemical processes.

               (g)Effects on human and animal health

               (i)Assessment of potential direct and indirect interactions between the GMHP and persons working with or coming into contact with the GMHPs, including through pollen or dust from a processed GMHP, and assessment of the adverse effects of those interactions on human health;

               (ii)For GMHPs not destined for human consumption, but where the recipient or parental organism(s) may be considered for human consumption, assessment of the likelihood of and possible adverse effects on human health due to accidental intake;

               (iii)Assessment of the potential adverse effects on animal health due to accidental consumption of the GMHP or of material from that plant by animals;

               (iv)Conclusions on the effects on human and animal health.

               (h)Overall risk evaluation and conclusions.

               A summary of all the conclusions under each area of risk shall be provided.

               The summary shall take into account the risk characterisation in accordance with steps 1 to 4 of the methodology described in Section C.3 of Annex II and the risk management strategies proposed in accordance with point 5 of Section C.3 of Annex II.

               5.Description of detection and identification techniques for the GMHP.

               6.Information about previous releases of the GMHP, if applicable."

               (4)Section A of Annex IV is amended as follows:

               (a)point 1 is replaced by the following:

               "1.proposed commercial names of the products and names of GMOs contained therein, and a proposal for a unique identifier for the GMO, developed in accordance with Commission Regulation (EC) No 65/2004*. After the consent any new commercial names should be provided to the competent authority,

               _______________

               *Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5)."

               (b)point 7 is replaced by the following:

               "7.methods for detection, identification and, where appropriate, quantification of the transformation event; samples of the GMO(s) and their control samples, and information as to the place where the reference material can be accessed. Information that cannot be placed, for confidentiality reasons, in the publicly accessible part of the register(s) referred to in Article 31(2) should be identified,".


title: COMMISSION DIRECTIVE (EU) .../… amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council on end-of life vehicles

text:
               COMMISSION DIRECTIVE (EU) .../…

               of 15.11.2017

               amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council on end-of life vehicles

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles
                  1
               , and in particular Article 4(2)(b),

               Whereas:

               (1)Article 4(2)(a) of Directive 2000/53/EC prohibits the use of lead, mercury, cadmium and hexavalent chromium in materials and components of vehicles put on the market after 1 July 2003.

               (2)Annex II to Directive 2000/53/EC lists vehicle materials and components exempt from the prohibition set out in Article 4(2)(a) thereof. That Annex is to be amended on a regular basis according to technical and scientific progress and exemptions 2(c), 3 and 5 regarding the use of lead are to be reviewed.

               (3)An assessment of technical and scientific progress has demonstrated that the use of lead remains unavoidable for the materials and components covered by exemption 2(c). However, current information suggests that lead substitutes may become available for those material and components in the near future. For some materials and components, lead substitutes are expected to become available sooner than for others, and therefore it is appropriate to split exemption 2(c) into two sub-entries with different review dates according to the progress in the development of such substitutes.

               (4)The assessment of technical and scientific progress has also demonstrated that the use of lead remains unavoidable for the materials and components covered by exemption 3. Possible substitutes exist but have to be developed further. A new review date for that exemption should therefore be set, taking into account the progress in the development of substitutes.

               (5)Finally, the assessment of technical and scientific progress has demonstrated that for some materials and components covered by exemption 5 lead alternatives already exist but are not usable in all vehicles covered by the exemption. For the other materials and components covered by exemption 5, the use of lead is still unavoidable. Consequently, that exemption should be split into two sub-entries. For the materials and components for which alternatives exist, an expiry date for the exemption should be set which allows necessary time to ensure that the use of lead is avoidable in all vehicles concerned. For the exemption covering materials and components for which the use of lead is still unavoidable, a new review date should be set, taking into account the progress in the development of substitutes.

               (6)The measures provided for in this Directive are in accordance with the opinion of the committee established by Article 39 of Directive 2008/98/EC of the European Parliament and of the Council
                  2
               ,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Annex II to Directive 2000/53/EC is replaced by the text set out in the Annex to this Directive.

               Article 2

               (1)Member States shall adopt and publish by [Date - six months after the entry into force of this Directive] the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               (2)Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

               Article 3

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels,

                  For the Commission

                  The President

                     (1)

                        OJ L 269, 21.10.2000, p. 34.

                     (2)

                        OJ L 312, 22.11.2008, p. 3.

    ---documentbreak---

               ANNEX

               "Annex II"

               Materials and components exempt from Article 4(2)(a)

               A maximum concentration value up to 0.1 % by weight in homogeneous material for lead, hexavalent chromium and mercury and up to 0.01 % by weight in homogeneous material for cadmium shall be tolerated.

               Spare parts put on the market after 1 July 2003 which are used for vehicles put on the market before 1 July 2003, except for wheel balance weights, carbon brushes for electric motors and brake linings, shall be exempted from the provisions of Article 4(2)(a) of Directive 2000/53/EC.

                        Materials and components

                        Scope and expiry date of the exemption

                        To be labelled or made identifiable in accordance with Article 4(2)(b)(iv)

                        Lead as an alloying element

                        1(a). Steel for machining purposes and batch hot dip galvanised steel components containing up to 0.35 % lead by weight

                        1(b). Continuously galvanised steel sheet containing up to 0.35 % lead by weight

                        Vehicles type approved before 1 January 2016 and spare parts for these vehicles

                        2(a). Aluminium for machining purposes with a lead content up to 2 % by weight

                        As spare parts for vehicles put on the market before 1 July 2005

                        2(b). Aluminium with a lead content up to 1.5 % by weight

                        As spare parts for vehicles put on the market before 1 July 2008

                        2(c)(i). Aluminium alloys for machining purposes with a lead content up to 0.4 % by weight

                        (1)

                        2(c)(ii). Aluminium alloys not included in entry 2(c)(i)with a lead content up to 0.4 % by weight (1a)

                        (2)

                        3. Copper alloys containing up to 4 % lead by weight

                        (1)

                        4(a). Bearing shells and bushes

                        As spare parts for vehicles put on the market before 1 July 2008

                        4(b). Bearing shells and bushes in engines, transmissions and air conditioning compressors

                        As spare parts for vehicles put on the market before 1 July 2011

                        Lead and lead compounds in components

                        5(a). Lead in batteries in high voltage systems (2a) that are used only for propulsion in M1 and N1 vehicles

                        Vehicles type approved before 1 January 2019 and spare parts for these vehicles

                        X

                        5(b). Lead in batteries for battery applications not included in entry 5(a)

                        (1)

                        X

                        6. Vibration dampers

                        Vehicles type approved before 1 January 2016 and spare parts for these vehicles

                        X

                        7(a). Vulcanising agents and stabilisers for elastomers in brake hoses, fuel hoses, air ventilation hoses, elastomer/metal parts in the chassis applications, and engine mountings

                        As spare parts for vehicles put on the market before 1 July 2005

                        7(b). Vulcanising agents and stabilisers for elastomers in brake hoses, fuel hoses, air ventilation hoses, elastomer/metal parts in the chassis applications, and engine mountings containing up to 0.5 % lead by weight

                        As spare parts for vehicles put on the market before 1 July 2006

                        7(c). Bonding agents for elastomers in powertrain applications containing up to 0.5 % lead by weight

                        As spare parts for vehicles put on the market before 1 July 2009

                        8(a). Lead in solders to attach electrical and electronic components to electronic circuit boards and lead in finishes on terminations of components other than electrolyte aluminium capacitors, on component pins and on electronic circuit boards

                        Vehicles type approved before 1 January 2016 and spare parts for these vehicles

                        X(4)

                        8(b). Lead in solders in electrical applications other than soldering on electronic circuit boards or on glass

                        Vehicles type approved before 1 January 2011 and spare parts for these vehicles

                        X(4)

                        8(c). Lead in finishes on terminals of electrolyte aluminium capacitors

                        Vehicles type approved before 1 January 2013 and spare parts for these vehicles

                        X(4)

                        8(d). Lead used in soldering on glass in mass airflow sensors

                        Vehicles type approved before 1 January 2015 and spare parts of such vehicles

                        X(4)

                        8(e). Lead in high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead)

                        (3)

                        X(4)

                        8(f)(a). Lead in compliant pin connector systems

                        Vehicles type approved before 1 January 2017 and spare parts for these vehicles

                        X(4)

                        8(f)(b). Lead in compliant pin connector systems other than the mating area of vehicle harness connectors

                        (3)

                        X(4)

                        8(g). Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages

                        (3)

                        X(4)

                        8(h). Lead in solder to attach heat spreaders to the heat sink in power semiconductor assemblies with a chip size of at least 1 cm² of projection area and a nominal current density of at least 1 A/mm2 of silicon chip area

                        Vehicles type approved before 1 January 2016 and after that date as spare parts for these vehicles

                        X(4)

                        8(i). Lead in solders in electrical glazing applications on glass except for soldering in laminated glazing

                        Vehicles type approved before 1 January 2016 and after that date as spare parts for these vehicles

                        X(4)

                        8(j). Lead in solders for soldering of laminated glazing

                        Vehicles type approved before 1 January 2020 and after that date as spare parts for these vehicles

                        X(4)

                        9. Valve seats

                        As spare parts for engine types developed before 1 July 2003

                        10(a). Electrical and electronic components which contain lead in a glass or ceramic, in a glass or ceramic matrix compound, in a glass-ceramic material, or in a glass-ceramic matrix compound.

                        This exemption does not cover the use of lead in:

                        -glass in bulbs and glaze of spark plugs,

                        -dielectric ceramic materials of components listed under 10(b), 10(c) and 10(d).

                        X(5) (for components other than piezo in engines)

                        10(b). Lead in PZT based dielectric ceramic materials of capacitors being part of integrated circuits or discrete semiconductors

                        10(c). Lead in dielectric ceramic materials of capacitors with a rated voltage of less than 125 V AC or 250 V DC

                        Vehicles type approved before 1 January 2016 and spare parts for these vehicles

                        10(d). Lead in the dielectric ceramic materials of capacitors compensating the temperature-related deviations of sensors in ultrasonic sonar systems

                        Vehicles type approved before 1 January 2017 and after that date as spare parts for these vehicles

                        11. Pyrotechnic initiators

                        Vehicles type approved before 1 July 2006 and spare parts for these vehicles

                        12. Lead-containing thermoelectric materials in automotive electrical applications to reduce CO2 emissions by recuperation of exhaust heat

                        Vehicles type approved before 1 January 2019 and spare parts for these vehicles

                        X

                        Hexavalent chromium

                        13(a). Corrosion preventive coatings

                        As spare parts for vehicles put on the market before 1 July 2007

                        13(b). Corrosion preventive coatings related to bolt and nut assemblies for chassis applications

                        As spare parts for vehicles put on the market before 1 July 2008

                        14. As an anti-corrosion agent of the carbon steel cooling system in absorption refrigerators in motorcaravans up to 0.75 weight - % in the cooling solution except where the use of other cooling technologies is practicable (i.e. available on the market for the application in motor caravans) and does not lead to negative environmental, health and/or consumer safety impacts

                        X

                        Mercury

                        15(a). Discharge lamps for headlight application

                        Vehicles type approved before 1 July 2012 and spare parts for these vehicles

                        X

                        15(b). Fluorescent tubes used in instrument panel displays

                        Vehicles type approved before 1 July 2012 and spare parts for these vehicles

                        X

                        Cadmium

                        16. Batteries for electrical vehicles

                        As spare parts for vehicles put on the market before 31 December 2008

               (1) This exemption shall be reviewed in 2021.

               (1a) Applies to aluminium alloys where lead is not intentionally introduced but is present due to the use of recycled aluminium.

               (2) This exemption shall be reviewed in 2024.

               (2a) Systems that have a voltage of >75VDC as defined in Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (OJ L 374, 27.12.2006, p. 10).

               (3) This exemption shall be reviewed in 2019.

               (4) Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.

               (5) Dismantling if, in correlation with entries 8(a) to 8(j), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.

               ------------------------------------------------------------------------------------------------------------"


title: COMMISSION DIRECTIVE (EU) .../… amending Directive 2009/128/EC of the European Parliament and of the Council as regards the establishment of harmonised risk indicators

text:
               COMMISSION DIRECTIVE (EU) .../…

               of 15.5.2019

               amending Directive 2009/128/EC of the European Parliament and of the Council as regards the establishment of harmonised risk indicators

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides
                  1
               , and in particular the second subparagraph of Article 15(1) thereof,

               Whereas:

               (1)Directive 2009/128/EC aims to reduce risks and impacts of pesticide use on human health and the environment and to promote the use of integrated pest management and of alternative approaches or techniques in order to reduce dependency on the use of pesticides.

               (2)In its report of October 2017 on Member State National Action Plans and on progress in the implementation of Directive 2009/128/EC on the sustainable use of pesticides
                  2
               , the Commission undertook to work with Member States towards reaching a consensus on the development of harmonised risk indicators.

               (3)In December 2017, in its response to the European Citizens Initiative “Ban glyphosate and protect people and the environment from toxic pesticides"
                  3
               , the Commission undertook to establish harmonised risk indicators in order to monitor trends in risk reduction from pesticide use at Union level.

               (4)It is necessary to establish harmonised risk indicators in order to measure the progress achieved in meeting those objectives at Union level, which will enable Member States to manage and to report on risk at national level.

               (5)Article 15(4) of Directive 2009/128/EC requires the Commission to calculate risk indicators at Union level using statistical data collected in accordance with Union legislation concerning statistics on plant protection products and other relevant data, in order to estimate trends in risks from pesticide use.

               (6)Article 1(3) of Regulation (EC) No 1185/2009 of the European Parliament and of the Council
                  4
                requires that the statistics produced in accordance with that Regulation, together with other relevant data, serve the purpose of Articles 4 and 15 of Directive 2009/128/EC, namely the establishment of National Action Plans and the calculation of indicators. To date, no harmonised approach at Union level for collecting statistics on the use of plant protection products has been achieved under Regulation (EC) No 1185/2009 and therefore no such data is available.

               (7)Article 53 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council
                  5
                allows, in special circumstances, Member States to authorise for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be controlled by any other reasonable means. In these cases, Member States may authorise plant protection products containing either approved or non-approved active substances.

               (8)A harmonised risk indicator can only be based on statistical data collected in accordance with the Union legislation concerning statistics on plant protection products and other relevant data, and, in the absence of statistics on the use of plant protection products, the only such relevant and currently available data are statistics on the placing on the market of plant protection products, and the number of authorisations granted by Member States in special circumstances under Article 53 of Regulation (EC) No 1107/2009. Such indicators should be supplemented with other indicators so that other risk elements can be included.

               (9)It is appropriate that the categorisation of active substances used in this Directive mirror the categorisation provided for in Regulation (EC) No 1107/2009, as either low-risk active substances, candidates for substitution or other active substances, based, amongst others, on the classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council
                  6
               .

               (10)Active substances under Regulation (EC) No 1107/2009 can be either chemical active substances or micro-organisms. Directive 2009/128/EC requires Member States to give wherever possible priority to non-chemical methods of pest management. It is therefore appropriate, when establishing harmonised risk indicators, to categorise chemical active substances and micro-organisms separately.

               (11)In cases where Member States grant authorisations under Article 53 of Regulation (EC) No 1107/2009 concerning non-approved active substances, the quantities of non-approved active substances contained in the plant protection products subsequently placed on the market are communicated by Members States to the Commission in accordance with Article 3 of Regulation (EC) No 1185/2009. To date, there is no harmonised approach at Union level for collecting data on the specific quantities of approved active substances contained in plant protection products placed on the market linked to authorisations granted under Article 53 of Regulation (EC) No 1107/2009.

               (12)By combining the statistics produced in accordance with Regulation (EC) No 1185/2009 and the information on active substances in accordance with Regulation (EC) No 1107/2009, including if they are low risk active substances, candidates for substitution, or other active substances, a method of calculation can be established to produce a hazard-based harmonised risk indicator which estimates potential risks from pesticide use.

               (13)Pending the putting in place of a Union-wide harmonised data collection system on the quantities of active substances placed on the market under Article 53 of Regulation (EC) No 1107/2009, it is justified to establish a harmonised risk indicator based on the number of authorisations granted under that Article.

               (14)In order to calculate harmonised risk indicators to reflect the relative risk of using plant protection products containing different categories of approved active substances and non-approved active substances, weighting factors should be established for this purpose.

               (15)In order to measure progress in the area with a reasonable frequency, and given that Member States are required to produce data under Regulation (EC) No 1185/2009 on an annual basis and transmit it to Eurostat within 12 months of the end of the reference year, the calculation of harmonised risk indicators should be performed annually, and published at the latest 20 months after the end of the reference year in question.

               (16)The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1
               Amendment to Annex IV to Directive 2009/128/EC

               Annex IV to Directive 2009/128/EC is replaced by the text in the Annex to this Directive.

               Article 2
               Transposition

               1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [Office of publications: please insert date – 3 months after entry into force] at the latest.

               When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               2.Member States shall communicate to the Commission the text of the provisions which they adopt in the field covered by this Directive.

               Article 3
               Entry into force

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 4
               Addressees

               This Directive is addressed to the Member States.

               Done at Brussels, 15.5.2019

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 309, 24.11.2009, p. 71.

                     (2)

                        Report from the Commission to the European Parliament and the Council of October 2017 on Member State National Action Plans and on progress in the implementation of Directive 2009/128/EC on the sustainable use of pesticides - COM(2017) 587 final.

                     (3)

                        Communication from the Commission of 12 December 2017 on the European Citizens' Initiative "Ban glyphosate and protect people and the environment from toxic pesticides" - C(2017)8414 final.

                     (4)

                        Regulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides (OJ L 324, 10.12.2009, p. 1).

                     (5)

                        Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

                     (6)

                        Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

    ---documentbreak---

               “ANNEX IV”

               Section 1: Harmonised Risk Indicators

               The harmonised risk indicators are listed in Sections 2 and 3 of this Annex.

               Section 2: Harmonised Risk Indicator 1: Hazard-based Harmonised Risk Indicator based on the quantities of active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009

               1.This indicator shall be based on statistics on the quantities of active substances placed on the market in plant protection products under Regulation (EC) No 1107/2009, provided to the Commission (Eurostat) under Annex I (Statistics on the placing on the market of pesticides) of Regulation (EC) No 1185/2009. Those data are categorised into 4 Groups, which are divided into 7 Categories.

               2.The following general rules shall apply for the calculation of Harmonised Risk Indicator 1:

               (a)the Harmonised Risk Indicator 1 shall be calculated on the basis of the categorisation of active substances into the 4 Groups and 7 Categories set out in Table 1;

               (b)the active substances in Group 1 (categories A and B) shall be those listed in Part D of the Annex to implementing Regulation (EU) No 540/2011;

               (c)the active substances in Group 2 (categories C and D) shall be those listed in Parts A and B of the Annex to implementing Regulation (EU) No 540/2011;

               (d)the active substances in Group 3 (categories E and F) shall be those listed in Part E of the Annex to implementing Regulation (EU) No 540/2011;

               (e)the active substances in Group 4 (category G) shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to implementing Regulation (EU) No 540/2011;

               (f)the weightings in row (vi) in Table 1 shall apply.

               3.Harmonised Risk Indicator 1 shall be calculated by multiplying the annual quantities of active substances placed on the market for each Group in Table 1 by the relevant hazard weighting set out in Row vi, followed by the aggregation of the results of these calculations.

               4.The quantities of active substances placed on the market for each Group and Category in Table 1 may be calculated.

               Table 1.Categorisation of active substances and hazard weightings for the purpose of calculating Harmonised Risk Indicator 1.

                        Row

                        Groups

                        1

                        2

                        3

                        4

                        (i)

                        Low-risk active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to implementing Regulation (EU) No 540/2011

                        Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to implementing Regulation (EU) No 540/2011

                        Active substances approved or deemed to be approved under Article 24 of Regulation (EC) No 1107/2009, which are candidates for substitution, and which are listed in Part E of the Annex to implementing Regulation (EU) No 540/2011

                        Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to implementing Regulation (EU) No 540/2011

                        (ii)

                        Categories

                        (iii)

                        A

                        B

                        C

                        D

                        E

                        F

                        G

                        (iv)

                        Micro-organisms

                        Chemical active substances

                        Micro-organisms

                        Chemical active substances

                        Which are not classified as:

                        Carcinogenic Category 1A or 1B

                        and/or

                        Toxic for Reproduction Category 1A or 1B

                        and/or

                        Endocrine disruptors

                        Which are classified as:

                        Carcinogenic Category 1A or 1B

                        and/or

                        Toxic for Reproduction Category 1A or 1B

                        and/or

                        Endocrine disruptors, where exposure of humans is negligible

                        (v)

                        Hazard Weightings applicable to quantities of active substances placed on the market in products authorised under Regulation (EC) No 1107/2009

                        (vi)

                        1

                        8

                        16

                        64

               5.The baseline for Harmonised Risk Indicator 1 shall be set at 100, and is equal to the average result of the above calculation for the period 2011-2013.

               6.The result of Harmonised Risk Indicator 1 shall be expressed by reference to the baseline.

               7.The Member States and the Commission shall calculate and publish the Harmonised Risk Indicator 1 in accordance with Article 15(2) and 15(4) of Directive 2009/128/EC for each calendar year and at the latest 20 months after the end of the year for which the Harmonised Risk Indicator 1 is being calculated.

               Section 3: Harmonised Risk Indicator 2: Harmonised Risk Indicator based on the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009

               1.This indicator shall be based on the number of authorisations granted for plant protection products under Article 53 of Regulation (EC) No 1107/2009 as communicated to the Commission in accordance with Article 53(1) of that Regulation. Those data are categorised into 4 Groups, which are divided into 7 Categories.

               2.The following general rules shall apply for the calculation of the Harmonised Risk Indicator 2:

               (a)the Harmonised Risk Indicator 2 shall be based on the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009. It shall be calculated on the basis of the categorisation of active substances into the 4 Groups and 7 Categories set out in Table 2 of this Section;

               (b)the active substances in Group 1 (categories A and B) are listed in Part D of the Annex to implementing Regulation (EU) No 540/2011;

               (c)the active substances in Group 2 (categories C and D) are those listed in Parts A and B of the Annex to implementing Regulation (EU) No 540/2011;

               (d)the active substances in Group 3 (categories E and F) shall be those listed in Part E of the Annex to implementing Regulation (EU) No 540/2011;

               (e)the active substances in Group 4 (category G) shall be those not approved under Regulation (EC) No 1107/2009, and therefore not listed in the Annex to implementing Regulation (EU) No 540/2011;

               (f)The weightings in row (vi) in Table 2 of this Section shall apply.

               3.The Harmonised Risk Indicator 2 shall be calculated by multiplying the number of authorisations granted for plant protection products under Article 53 of Regulation (EC) No 1107/2009 for each Group in Table 2 by the relevant hazard weighting set out in Row (vi), followed by the aggregation of the results of these calculations.

               Table 2.Categorisation of active substances and hazard weightings for the purpose of calculating Harmonised Risk Indicator 2

                        Row

                        Groups

                        1

                        2

                        3

                        4

                        (i)

                        Low-risk active substances which are approved or deemed to be approved under Article 22 of Regulation (EC) No 1107/2009, and which are listed in Part D of the Annex to implementing Regulation (EU) No 540/2011

                        Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, and not falling in other categories, and which are listed in Parts A and B of the Annex to implementing Regulation (EU) No 540/2011

                        Active substances approved or deemed to be approved under Article 24 of Regulation (EC) No 1107/2009, which are candidates for substitution, and which are listed in Part E of the Annex to implementing Regulation (EU) No 540/2011

                        Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore which are not listed in the Annex to implementing Regulation (EU) No 540/2011

                        (ii)

                        Categories

                        (iii)

                        A

                        B

                        C

                        D

                        E

                        F

                        G

                        (iv)

                        Micro-organisms

                        Chemical active substances

                        Micro-organisms

                        Chemical active substances

                        Which are not classified as:

                        Carcinogenic Category 1A or 1B

                        and/or

                        Toxic for Reproduction Category 1A or 1B

                        and/or

                        Endocrine disruptors

                        Which are classified as:

                        Carcinogenic Category 1A or 1B

                        and/or

                        Toxic for Reproduction Category 1A or 1B

                        and/or

                        Endocrine disruptors where exposure of humans is negligible

                        (v)

                        Hazard Weightings applicable to the number of authorisations granted under Article 53 of Regulation (EC) No 1107/2009

                        (vi)

                        1

                        8

                        16

                        64

               4.The baseline for Harmonised Risk Indicator 2 shall be set at 100, and is equal to the average result of the above calculation for the period 2011-2013.

               5.The result of the Harmonised Risk Indicator 2 shall be expressed by reference to the baseline.

               6.The Member States and the Commission shall calculate and publish the Harmonised Risk Indicator 2 in accordance with Article 15(2) and 15(4) of Directive 2009/128/EC for each calendar year and at the latest 20 months after the end of the year for which Harmonised Risk Indicator 2 is being calculated.