title: Commission Implementing Directive (EU) 2021/971 of 16 June 2021 amending Annex I to Council Directive 66/401/EEC on the marketing of fodder plant seed, Annex I to Council Directive 66/402/EEC on the marketing of cereal seed, Annex I to Council Directive 2002/54/EC on the marketing of beet seed, Annex I to Council Directive 2002/55/EC on the marketing of vegetable seed and Annex I to Council Directive 2002/57/EC on the marketing of seed of oil and fibre plants, as regards the use of biochemical and molecular techniques

text:
                  17.6.2021

                  EN

                  Official Journal of the European Union

                  L 214/62

         COMMISSION IMPLEMENTING DIRECTIVE (EU) 2021/971
         of 16 June 2021
         amending Annex I to Council Directive 66/401/EEC on the marketing of fodder plant seed, Annex I to Council Directive 66/402/EEC on the marketing of cereal seed, Annex I to Council Directive 2002/54/EC on the marketing of beet seed, Annex I to Council Directive 2002/55/EC on the marketing of vegetable seed and Annex I to Council Directive 2002/57/EC on the marketing of seed of oil and fibre plants, as regards the use of biochemical and molecular techniques
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), and in particular Article 21a thereof,
         Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (2), and in particular Article 21b thereof,
         Having regard to Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (3), and in particular Article 27 thereof,
         Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (4), and in particular Article 45 thereof,
         Having regard to Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (5), and in particular Article 24 thereof,
         Whereas:

                     (1)

                     In accordance with Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC, seed of the respective species may only be marketed in the Union if it has been examined and certified officially or under official supervision, in accordance with the rules for certification regarding generation of pre-basic seed, basic seed or certified seed.

                     (2)

                     In accordance with Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC, the examination for certification is based on visual phenotypic observation of the crop in the field by the certification authority of each Member State or under its supervision and in official post-control. The aforementioned Directives, however, do not explicitly refer to the use of any other technique to check varietal identity in the field or in post control in the context of certification a fact that may create lack of clarity with regard to its implementation.

                     (3)

                     Biochemical and molecular techniques (‘BMT’) make it possible to indicate information on the genetic structure of living organisms. The use of BMT enables certification authorities to identify the plant variety on the basis of laboratory analysis instead of visual phenotypic observation of the plants in the field.

                     (4)

                     BMT in plant breeding and seed testing are developing fast and their use in the seed sector is increasingly important. In the Seed Schemes of the Organisation for Economic Cooperation and Development (OECD) (6), procedures, measures and techniques have been laid down to enable the use of BMT as a supplementary tool for field inspections and control plot testing, when there are doubts as regards the seed varietal identity, for the purposes of phenotypic examination.

                     (5)

                     Bearing in mind that the use of BMT facilitates the further analysis of seed and plants, it is appropriate to amend Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC to explicitly allow the use of BMT as a supplementary method for the examination of the identity of the variety concerned, in case field inspections and official post control have left some doubt. This is necessary in order for Union law to be adapted to the development of scientific and technical knowledge and to align the Union legislation with the applicable international standards incorporated into the OECD Seed Schemes.

                     (6)

                     In order to ensure their consistent and systematic application in accordance with the most updated scientific and technical evidence, Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC should only refer to BMTs recognised by the International Union for the Protection of New Varieties of Plants (UPOV), the OECD and the International Seed Testing Association (ISTA), as those organisations set the relevant officially recognised international BMT standards in this respect.

                     (7)

                     The relevant Annexes to Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC should therefore be amended accordingly, to ensure clarity that BMT may be also used in case there is still doubt as to the varietal identity of the seed.

                     (8)

                     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
            Amendments to Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC
            Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC are amended as follows:

                        (1)

                        Annex I to Directive 66/401/EEC is amended in accordance with Part A of the Annex to this Directive;

                        (2)

                        Annex I to Directive 66/402/ECC is amended in accordance with Part B of the Annex to this Directive;

                        (3)

                        Annex I to Directive 2002/54/EC is amended in accordance with Part C of the Annex to this Directive;

                        (4)

                        Annex I to Directive 2002/55/EC is amended in accordance with Part D of the Annex to this Directive;

                        (5)

                        Annex I to Directive 2002/57/EC is amended in accordance with Part E of the Annex to this Directive.

            Article 2
            Transposition

               1.   Member States shall adopt and publish, by 31 August 2022 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 1 September 2022.
               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
            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, 16 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ 125, 11.7.1966, p. 2298.

            (2)  OJ 125, 11.7.1966, p. 2309.

            (3)  OJ L 193, 20.7.2002, p. 12.

            (4)  OJ L 193, 20.7.2002, p. 33.

            (5)  OJ L 193, 20.7.2002, p. 74.

            (6)  OECD Seed Schemes; Rules and Regulation 2021, Common Rules and Regulation 7.4.5, p. 3, https://www.oecd.org/agriculture/seeds/documents/oecd-seed-schemes-rules-and-regulations.pdf, and OECD Seed Schemes; Guidelines for control plot tests and field inspection for seed crops, July 2019, Part III, p. 31, https://www.oecd.org/agriculture/seeds/documents/guidelines-control-plot-and-field-inspection.pdf

            ANNEX
            Amendments to Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC, as referred to in Article 1
            PART A

               Amendment to Annex I to Directive 66/401/EEC

            In Annex I to Directive 66/401/EEC, the following point 7 is added:

                        ‘7.

                        In the case where, following the implementation of points 4 and 6, there is still doubt as to the varietal identity of the seed, the certification authority may use, for the examination of that identity, an internationally recognised and reproducible biochemical or molecular technique, in accordance with the applicable international standards.’

                  PART B

               Amendment to Annex I to Directive 66/402/EEC

            In Annex I to Directive 66/402/EEC, the following point 8 is added:

                        ‘8.

                        In the case where, following the implementation of points 3 and 7, there is still doubt as to the varietal identity of the seed, the certification authority may use, for the examination of that identity, an internationally recognised and reproducible biochemical or molecular technique, in accordance with the applicable international standards.’

                  PART C

               Amendment to Annex I to Directive 2002/54/EC

            In Part A. Crop of Annex I to Directive 2002/54/EC, the following point 5a is inserted between points 5 and 6:

                        ‘5a.

                        In the case where, following the implementation of points 2 to 5, there is still doubt as to the varietal identity of the seed, the certification authority may use, for the examination of that identity, an internationally recognised and reproducible biochemical or molecular technique, in accordance with the applicable international standards.’

                  PART D

               Amendment to Annex I to Directive 2002/55/EC

            In Annex I to Directive 2002/55/EC, the following point 3a is inserted between points 3 and 4:

                        ‘3a.

                        In the case where, following the implementation of points 1, 2 and 3, there is still doubt as to the varietal identity of the seed, the certification authority may use, for the examination of that identity, an internationally recognised and reproducible biochemical or molecular technique, in accordance with the applicable international standards.’

                  PART E

               Amendment to Annex I to Directive 2002/57/EC

            In Annex I to Directive 2002/57/EC, the following point 3a is inserted between points 3 and 4:

                        ‘3a.

                        In the case where, following the implementation of points 1 and 3, there is still doubt left as to the varietal identity of the seed, the certification authority may use, for the examination of that identity, an internationally recognised and reproducible biochemical or molecular technique, in accordance with the applicable international standards.’


title: Directive (EU) 2022/211 of the European Parliament and of the Council of 16 February 2022 amending Council Framework Decision 2002/465/JHA, as regards its alignment with Union rules on the protection of personal data

text:
                  18.2.2022

                  EN

                  Official Journal of the European Union

                  L 37/1

         DIRECTIVE (EU) 2022/211 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
         of 16 February 2022
         amending Council Framework Decision 2002/465/JHA, as regards its alignment with Union rules on the protection of personal data
         THE EUROPEAN PARLIAMENT AND THE COUNCIL OF TDHE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union, and in particular Article 16(2) thereof,
         Having regard to the proposal from the European Commission,
         After transmission of the draft legislative act to the national parliaments,
         Acting in accordance with the ordinary legislative procedure (1),
         Whereas:

                     (1)

                     Pursuant to Article 62(6) of Directive (EU) 2016/680 of the European Parliament and of the Council (2), the Commission is to review legal acts adopted by the Union, other than that Directive, which regulate the processing of personal data by the competent authorities for the purposes set out in Article 1(1) of that Directive. The purpose of that review is to assess the need to align those legal acts with that Directive and to make, where appropriate, the necessary proposals to amend them in order to ensure a consistent approach to the protection of personal data within the scope of that Directive. That review has led to the identification of Council Framework Decision 2002/465/JHA (3) as one of the legal acts to be amended.

                     (2)

                     The processing of personal data under Framework Decision 2002/465/JHA involves the processing, exchange and subsequent use of relevant information for the purposes set out in Article 82 of the Treaty on the Functioning of the European Union (TFEU). In the interests of consistency and the effective protection of personal data, the processing of personal data under Framework Decision 2002/465/JHA should comply with Directive (EU) 2016/680. It should be possible for personal data contained in information lawfully obtained by a joint investigation team to be processed for purposes other than those for which the team was set up, such as subsequent criminal or related administrative or civil procedures or parliamentary scrutiny, only in accordance with the conditions laid down in Directive (EU) 2016/680. Such processing of personal data should only be carried out in accordance with the conditions laid down in Directive (EU) 2016/680, including that it be carried out in accordance with Union or Member State law and be necessary and proportionate to its purpose.

                     (3)

                     In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union (TEU) and to the TFEU, Ireland is bound by Framework Decision 2002/465/JHA and is therefore taking part in the adoption of this Directive.

                     (4)

                     In accordance with Articles 1, 2 and 2a of Protocol No 22 on the position of Denmark annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Directive and is not bound by it or subject to its application.

                     (5)

                     The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council (4) and delivered an opinion on 10 March 2021.

                     (6)

                     Framework Decision 2002/465/JHA should therefore be amended accordingly,

               HAVE ADOPTED THIS DIRECTIVE:

            Article 1
            Amendment to Framework Decision 2002/465/JHA
            In Article 1(10) of Framework Decision 2002/465/JHA, the following subparagraph is added:

               ‘Insofar as the information used for purposes referred to in the first subparagraph, points (b), (c) and (d) includes personal data, it shall only be processed in accordance with Directive (EU) 2016/680 of the European Parliament and of the Council (*), and in particular Article 4(2) and Article 9(1) and (3) thereof.

            Article 2
            Transposition

               1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 11 March 2023. They shall immediately inform the Commission thereof.
               When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

               2.   Member States shall communicate to the Commission the text of the measures of national law 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 in accordance with the Treaties.

            Done at Strasbourg, 16 February 2022.

                  For the European Parliament

                  The President

               R. METSOLA

                  For the Council

                  The President

               C. BEAUNE

            (1)  Position of the European Parliament of 14 December 2021 (not yet published in the Official Journal) and decision of the Council of 25 January 2022.

            (2)  Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89).

            (3)  Council Framework Decision 2002/465/JHA of 13 June 2002 on joint investigation teams (OJ L 162, 20.6.2002, p. 1).

            (4)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).


title: Council Directive (EU) 2020/2020 of 7 December 2020 amending Directive 2006/112/EC as regards temporary measures in relation to value added tax applicable to COVID-19 vaccines and in vitro diagnostic medical devices in response to the COVID-19 pandemic

text:
                  11.12.2020

                  EN

                  Official Journal of the European Union

                  L 419/1

         COUNCIL DIRECTIVE (EU) 2020/2020
         of 7 December 2020
         amending Directive 2006/112/EC as regards temporary measures in relation to value added tax applicable to COVID-19 vaccines and in vitro diagnostic medical devices in response to the COVID-19 pandemic
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union, and in particular Article 113 thereof,
         Having regard to the proposal from the European Commission,
         After transmission of the draft legislative act to the national parliaments,
         Having regard to the opinion of the European Parliament (1),
         Having regard to the opinion of the European Economic and Social Committee (2),
         Acting in accordance with a special legislative procedure,
         Whereas:

                     (1)

                     On 30 January 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a ‘public health emergency of international concern’ and, on 11 March 2020, characterised it as a pandemic.

                     (2)

                     The Union has joined forces with the WHO and a group of global actors in an unprecedented effort of global solidarity to fight the pandemic. That effort aims to support the development and equitable distribution of in vitro diagnostic medical devices, treatments and vaccines required to control and combat COVID-19.

                     (3)

                     In view of the alarming increase in the number of COVID-19 cases in the Member States, in its communication of 17 June 2020 the Commission has proposed an EU strategy for COVID-19 vaccines. The aim of that strategy is to accelerate the development, manufacturing and deployment of vaccines against the virus to help protect people in the Union. While an effective and safe vaccine against COVID-19 is the most likely permanent solution to the pandemic, testing is indispensable to contain the pandemic.

                     (4)

                     In the area of value added tax (VAT), the Commission has taken exceptional measures to help victims of the pandemic. On 3 April 2020, the Commission adopted Decision (EU) 2020/491 (3) enabling Member States to temporarily exempt from VAT and import duties vital goods needed to combat the effects of the COVID-19 outbreak, including COVID-19 in vitro diagnostic medical devices. However, that Decision covers only importation and not intra-Community or domestic supplies.

                     (5)

                     Council Directive 2006/112/EC (4) contains tools allowing Member States to partly alleviate the cost of COVID-19 vaccination and testing, notably through a VAT exemption without deductibility for hospital and medical care and a reduced VAT rate available for vaccines. However, that Directive does not allow Member States to apply a reduced VAT rate to the supply of COVID-19 in vitro diagnostic medical devices or services closely linked to such devices. Nor does it allow Member States to grant an exemption with deductibility of VAT paid at the preceding stage in respect of the supply of COVID-19 vaccines and in vitro diagnostic medical devices or services closely linked to such vaccines and devices.

                     (6)

                     In 2018, the Commission presented a proposal to amend Directive 2006/112/EC as regards VAT rates (the ‘2018 proposal’). If adopted by Council, it would, amongst other things, allow Member States, under certain conditions, to apply a reduced VAT rate to the supply of COVID-19 in vitro diagnostic medical devices as well as of services closely linked to such devices. In addition, the 2018 proposal would allow Member States, under certain conditions, to grant an exemption with deductibility of VAT paid at the preceding stage to the supply of COVID-19 vaccines and in vitro diagnostic medical devices as well as of services closely linked to such vaccines and devices. The 2018 proposal would allow Member States to apply those rates, if such supply benefits only the final consumer and pursues an objective of general interest.

                     (7)

                     However, since the adoption of the 2018 proposal is still pending before the Council, it is necessary to take immediate action in order to adapt Directive 2006/112/EC to the exceptional circumstances caused by the COVID-19 pandemic. The aim of such action is to ensure that the supply of COVID-19 vaccines and in vitro diagnostic medical devices as well as of services closely linked to such vaccines and devices become more affordable in the Union as soon as possible.

                     (8)

                     To that end, Member States should be allowed to apply a reduced VAT rate to the supply of COVID-19 in vitro diagnostic medical devices and services closely linked to such devices, or to grant an exemption with deductibility of VAT paid at the preceding stage in respect of the supply of COVID-19 vaccines and in vitro diagnostic medical devices, approved as such by the Commission or by them, as well as of services closely linked to such vaccines and devices.

                     (9)

                     The possibility to apply a reduced VAT rate to the supply of COVID-19 in vitro diagnostic medical devices and services closely linked to such devices or to grant an exemption with deductibility of VAT paid at the preceding stage in respect of the supply of COVID-19 vaccines and in vitro diagnostic medical devices and services closely linked to such vaccines and devices, should be limited in time. That possibility should be allowed only for the duration of the exceptional circumstances caused by the COVID-19 pandemic. Due to the uncertainty of the duration of those exceptional circumstances, the possibility to apply a reduced VAT rate or to grant an exemption with deductibility of VAT paid at the preceding stage to such supplies should remain in place until 31 December 2022. Before the end of that period, the possibility to apply the reduction or to grant the exemption should be reviewed in light of the situation of the pandemic and, if necessary, it should be possible to extend that period. If the 2018 proposal were to be adopted and become applicable before the expiry of that period, these temporary measures aimed at adapting Directive 2006/112/EC to the COVID-19 pandemic would no longer serve their purpose.

                     (10)

                     Since the objective of this Directive to ensure, as soon as possible, more affordable access to the supply of COVID-19 vaccines and in vitro diagnostic medical devices as well as of services closely linked to such vaccines and devices in the Union cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

                     (11)

                     Directive 2006/112/EC should therefore be amended accordingly.

                     (12)

                     In view of the COVID-19 pandemic and the urgency to address the associated public health crisis, it was considered to be appropriate to provide for an exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.

                     (13)

                     Given the urgency of the situation related to the COVID-19 pandemic, this Directive should enter into force on the day folllowing its publication in the Official Journal of the European Union,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            The following Article is inserted in Directive 2006/112/EC:

                  ‘Article 129a

                     1.   Member States may take one of the following measures:

                                 (a)

                                 apply a reduced rate to the supply of COVID-19 in vitro diagnostic medical devices and services closely linked to those devices;

                                 (b)

                                 grant an exemption with deductibility of VAT paid at the preceding stage in respect of the supply of COVID-19 in vitro diagnostic medical devices and services closely linked to those devices.

                           Only COVID-19 in vitro diagnostic medical devices that are in conformity with the applicable requirements set out in Directive 98/79/EC of the European Parliament and of the Council (*) or Regulation (EU) 2017/746 of the European Parliament and of the Council (**) and other applicable Union legislation shall be eligible for the measures provided for in the first subparagraph.

                     2.   Member States may grant an exemption with deductibility of VAT paid at the preceding stage in respect of the supply of COVID-19 vaccines and services closely linked to those vaccines.
                     Only COVID-19 vaccines authorised by the Commission or by Member States shall be eligible for the exemption provided for in the first subparagraph.

                     3.   This Article shall apply until 31 December 2022.

            Article 2

               1.   Where Member States decide to apply a reduced rate or grant an exemption referred to in Article 1, the laws, regulations and administrative provisions, which are adopted and published by them and which are necessary to comply with this Directive, 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 within two months of their adoption.

            Article 3
            This Directive shall enter into force on the 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, 7 December 2020.

                  For the Council

                  The President

               M. ROTH

            (1)  Opinion of 26 November 2020 (not yet published in the Official Journal).

            (2)  Opinion of 2 December 2020 (not yet published in the Official Journal).

            (3)  Commission Decision (EU) 2020/491 of 3 April 2020 on relief from import duties and VAT exemption on importation granted for goods needed to combat the effects of the COVID-19 outbreak during 2020 (OJ L 103 I, 3.4.2020, p. 1).

            (4)  Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1).


title: Commission Directive (EU) 2020/2088 of 11 December 2020 amending Annex II to Directive 2009/48/EC of the European Parliament and of the Council as regards the labelling of allergenic fragrances in toys (Text with EEA relevance)

text:
                  15.12.2020

                  EN

                  Official Journal of the European Union

                  L 423/53

         COMMISSION DIRECTIVE (EU) 2020/2088
         of 11 December 2020
         amending Annex II to Directive 2009/48/EC of the European Parliament and of the Council as regards the labelling of allergenic fragrances in toys
         (Text with EEA relevance)
         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 point (b) of the first subparagraph of Article 46(1) thereof,
         Whereas:

                     (1)

                     Directive 2009/48/EC lays down a general obligation to list on the toy, on an affixed label, on the packaging or in an accompanying leaflet, if added to a toy, the names of 11 allergenic fragrances if the concentrations of those fragrances exceed 100 mg/kg in the toy or components thereof. Those allergenic fragrances are listed in the table in the third paragraph of point 11 of Part III of Annex II to that Directive.

                     (2)

                     The Scientific Committee on Consumer Safety (SCCS), which assists the Commission as an independent risk assessment body in the area of cosmetic products, notes in its opinion of 26 and 27 June 2012 (2) that contact allergy to fragrances is a common, significant and relevant problem in Europe and that exposure to fragrances occurs from the use of other consumer products, such as toys. The SCCS also notes that, in recent years, it has become a trend to add fragrance chemicals to many types of consumer products, such as children’s toys, which may contribute significantly to the fragrance exposure of the consumer by the dermal route. The SCCS adds that the consumer is exposed to fragrance substances from a wide variety of cosmetic products, other consumer products, pharmaceuticals and occupational exposures, and that all those exposures are of importance in the context of contact allergy as it is not the source of exposure that is critical, but the cumulative dose per unit area. In the opinion, a number of established contact allergens in humans are listed in Table 13-1.

                     (3)

                     A survey of allergenic substances in products for children carried out by the Environmental Protection Agency in Denmark (3) shows the presence of allergenic fragrances in toys, namely modelling clays, slimes, a doll, a teddy bear, and rubber bands.

                     (4)

                     The Expert Group on Toys Safety advises the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety. The mission of its subgroup on Chemicals in Toys (subgroup Chemicals) is to provide advice with regard to chemical substances which may be used in toys.

                     (5)

                     The Expert Group on Toys Safety recalled, at its meeting on 13 September 2019 (4), that an allergenic substance, whether present in cosmetic products or in toys, is always allergenic. That so-called intrinsic property of the substance is independent from the use of the substance and is therefore present irrespective of whether the allergenic substance is used in cosmetics or in toys. Consequently, the Expert Group considered that an allergenic substance presenting a risk in cosmetic products could equally present a risk in toys. It therefore underlined the importance to take thorough account of the opinions of the SCCS and of its predecessor committees on allergenic fragrances in cosmetic products when regulating allergenic fragrances in toys.

                     (6)

                     At the meeting of the subgroup Chemicals of 3 May 2018 (5), the majority of its members concluded that the established contact allergens in humans listed in Table 13-1 of the SCCS opinion of 26 and 27 June 2012 should be added to the list of allergenic fragrances that have to be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, laid down in the table in the third paragraph of point 11 of Part III of Annex II to Directive 2009/48/EC.

                     (7)

                     On 13 September 2019, the Expert Group on Toys Safety confirmed the conclusions of the subgroup Chemicals.

                     (8)

                     At its meeting on 13 September 2019, the Expert Group on Toys Safety noted that entry 4 in the table in the third paragraph of point 11 of Part III of Annex II to Directive 2009/48/EC on citronellol, CAS number 106-22-9, covers only the mixture of the two enantiomeric forms of citronellol. The labelling requirements should however, according to the Expert Group, also cover the two individual enantiomeric forms listed as CAS numbers 1117-61-9 and 7540-51-4 in Table 13-1 of the SCCS opinion of 26 and 27 June 2012.

                     (9)

                     In light of the SCCS opinion of 26 and 27 June 2012 and the recommendation of the Expert Group on Toys Safety of 13 September 2019, the allergenic fragrances listed in Table 13-1 of the SCCS opinion of 26 and 27 June 2012 should be subject to labelling requirements when present in toys. The fragrances that are not yet subject to a prohibition or labelling requirements laid down in Directive 2009/48/EC, should therefore be included in the table in the third paragraph of point 11 of Part III of Annex II to that Directive.

                     (10)

                     Directive 2009/48/EC should therefore be amended accordingly.

                     (11)

                     The measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 47(1) of Directive 2009/48/EC,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Annex II to Directive 2009/48/EC is amended in accordance with the Annex to this Directive.

            Article 2

               1.   Member States shall adopt and publish, by 4 July 2022 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 5 July 2022.
               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, 11 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 170, 30.6.2009, p. 1.

            (2)  SCCS opinion on fragrance allergens in cosmetic products, 26 – 27 June 2012 (SCCS/1459/11). http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_102.pdf

            (3)  Ministry of Environment and Food of Denmark – Environmental Protection Agency. Survey of allergenic substances in products targeted children – toys and cosmetic products. Survey of Chemical Substances in Consumer Products No 148, 2016.
         https://www2.mst.dk/Udgiv/publications/2016/08/978-87-93529-00-7.pdf

            (4)  Minutes of the meeting of the Expert Group on Toys Safety of 13 September 2019 https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=17996

            (5)  Minutes of the Meeting of the subgroup Chemicals of the Expert Group on Toy Safety of 3 May 2018. https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeetingDoc&docid=19025

            ANNEX
            In the third paragraph of point 11 of Part III of Annex II, the table is amended as follows:

                        (1)

                        entry 4 is replaced by the following:

                                    No

                                    Name of the allergenic fragrance

                                    CAS number

                                    ‘(4)

                                    Citronellol

                                    106-22-9; 1117-61-9; 7540-51-4’

                        (2)

                        the following entries are added:

                                    No

                                    Name of the allergenic fragrance

                                    CAS number

                                    ‘(12)

                                    Acetylcedrene

                                    32388-55-9

                                    (13)

                                    Amyl salicylate

                                    2050-08-0

                                    (14)

                                    trans-Anethole

                                    4180-23-8

                                    (15)

                                    Benzaldehyde

                                    100-52-7

                                    (16)

                                    Camphor

                                    76-22-2; 464-49-3

                                    (17)

                                    Carvone

                                    99-49-0; 6485-40-1; 2244-16-8

                                    (18)

                                    beta-Caryophyllene (ox.)

                                    87-44-5

                                    (19)

                                    Rose ketone-4 (Damascenone)

                                    23696-85-7

                                    (20)

                                    alpha-Damascone (TMCHB)

                                    43052-87-5; 23726-94-5

                                    (21)

                                    cis-beta-Damascone

                                    23726-92-3

                                    (22)

                                    delta-Damascone

                                    57378-68-4

                                    (23)

                                    Dimethylbenzyl carbinyl acetate (DMBCA)

                                    151-05-3

                                    (24)

                                    Hexadecanolactone

                                    109-29-5

                                    (25)

                                    Hexamethylindanopyran

                                    1222-05-5

                                    (26)

                                    (DL)-Limonene

                                    138-86-3

                                    (27)

                                    Linalyl acetate

                                    115-95-7

                                    (28)

                                    Menthol

                                    1490-04-6; 89-78-1; 2216-51-5

                                    (29)

                                    Methyl salicylate

                                    119-36-8

                                    (30)

                                    3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol

                                    67801-20-1

                                    (31)

                                    alpha-Pinene

                                    80-56-8

                                    (32)

                                    beta-Pinene

                                    127-91-3

                                    (33)

                                    Propylidene phthalide

                                    17369-59-4

                                    (34)

                                    Salicylaldehyde

                                    90-02-8

                                    (35)

                                    alpha-Santalol

                                    115-71-9

                                    (36)

                                    beta-Santalol

                                    77-42-9

                                    (37)

                                    Sclareol

                                    515-03-7

                                    (38)

                                    alpha-Terpineol

                                    10482-56-1; 98-55-5

                                    (39)

                                    Terpineol (mixture of isomers)

                                    8000-41-7

                                    (40)

                                    Terpinolene

                                    586-62-9

                                    (41)

                                    Tetramethyl acetyloctahydro naphthalenes

                                    54464-57-2; 54464-59-4; 68155-66-8; 68155-67-9

                                    (42)

                                    Trimethyl benzenepropanol (Majantol)

                                    103694-68-4

                                    (43)

                                    Vanillin

                                    121-33-5

                                    (44)

                                    Cananga odorata and Ylang-ylang oil

                                    83863-30-3; 8006-81-3

                                    (45)

                                    Cedrus atlantica bark oil

                                    92201-55-3; 8000-27-9

                                    (46)

                                    Cinnamomum cassia leaf oil

                                    8007-80-5

                                    (47)

                                    Cinnamomum zeylanicum bark oil

                                    84649-98-9

                                    (48)

                                    Citrus aurantium amara flower oil

                                    8016-38-4

                                    (49)

                                    Citrus aurantium amara peel oil

                                    72968-50-4

                                    (50)

                                    Citrus bergamia peel oil expressed

                                    89957-91-5

                                    (51)

                                    Citrus limonum peel oil expressed

                                    84929-31-7

                                    (52)

                                    Citrus sinensis (syn.: Aurantium dulcis) peel oil expressed

                                    97766-30-8; 8028-48-6

                                    (53)

                                    Cymbopogon citratus/schoenanthus oils

                                    89998-14-1; 8007-02-01; 89998-16-3

                                    (54)

                                    Eucalyptus spp. leaf oil

                                    92502-70-0; 8000-48-4

                                    (55)

                                    Eugenia caryophyllus leaf/flower oil

                                    8000-34-8

                                    (56)

                                    Jasminum grandiflorum/officinale

                                    84776-64-7; 90045-94-6; 8022-96-6

                                    (57)

                                    Juniperus virginiana

                                    8000-27-9; 85085-41-2

                                    (58)

                                    Laurus nobilis fruit oil

                                    8007-48-5

                                    (59)

                                    Laurus nobilis leaf oil

                                    8002-41-3

                                    (60)

                                    Laurus nobilis seed oil

                                    84603-73-6

                                    (61)

                                    Lavandula hybrida

                                    91722-69-9

                                    (62)

                                    Lavandula officinalis

                                    84776-65-8

                                    (63)

                                    Mentha piperita

                                    8006-90-4; 84082-70-2

                                    (64)

                                    Mentha spicata

                                    84696-51-5

                                    (65)

                                    Narcissus spp.

                                    Diverse, including 90064-25-8

                                    (66)

                                    Pelargonium graveolens

                                    90082-51-2; 8000-46-2

                                    (67)

                                    Pinus mugo

                                    90082-72-7

                                    (68)

                                    Pinus pumila

                                    97676-05-6

                                    (69)

                                    Pogostemon cablin

                                    8014-09-3; 84238-39-1

                                    (70)

                                    Rose flower oil (Rosa spp.)

                                    Diverse, including 8007-01-0, 93334-48-6, 84696-47-9, 84604-12-6, 90106-38-0, 84604-13-7, 92347-25-6

                                    (71)

                                    Santalum album

                                    84787-70-2; 8006-87-9

                                    (72)

                                    Turpentine (oil)

                                    8006-64-2; 9005-90-7; 8052-14-0’


title: Commission Directive (EU) 2020/2089 of 11 December 2020 amending Annex II to Directive 2009/48/EC of the European Parliament and of the Council as regards the prohibition of allergenic fragrances in toys (Text with EEA relevance)

text:
                  15.12.2020

                  EN

                  Official Journal of the European Union

                  L 423/58

         COMMISSION DIRECTIVE (EU) 2020/2089
         of 11 December 2020
         amending Annex II to Directive 2009/48/EC of the European Parliament and of the Council as regards the prohibition of allergenic fragrances in toys
         (Text with EEA relevance)
         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 point (b) of the first subparagraph of Article 46(1) thereof,
         Whereas:

                     (1)

                     Directive 2009/48/EC lays down a general prohibition of 55 allergenic fragrances in toys, as listed in the table in the first paragraph of point 11 of Part III of Annex II to that Directive, in order to protect children from allergies that those fragrances can cause when used in toys.

                     (2)

                     The Scientific Committee on Consumer Safety (SCCS), which assists the Commission as an independent risk assessment body in the area of cosmetic products, notes in its opinion of 26 and 27 June 2012 (2) that contact allergy to fragrances is a common, significant and relevant problem in Europe, and that exposure to fragrances occurs from the use of other consumer products, such as toys. The SCCS also notes that, in recent years, it has become a trend to add fragrance chemicals to many types of consumer products, such as children’s toys, which may contribute significantly to the fragrance exposure of the consumer by the dermal route. The SCCS adds that the consumer is exposed to fragrance substances from a wide variety of cosmetic products, other consumer products, pharmaceuticals and occupational exposures, and that all those exposures are of importance in the context of contact allergy as it is not the source of exposure that is critical, but the cumulative dose per unit area.

                     (3)

                     A survey of allergenic substances in products for children carried out by the Environmental Protection Agency in Denmark (3) shows the presence of allergenic fragrances in toys, namely modelling clays, slimes, a doll, a teddy bear, and rubber bands.

                     (4)

                     The Expert Group on Toys Safety advises the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety. The mission of its subgroup on Chemicals in Toys (subgroup Chemicals) is to provide advice with regard to chemical substances which may be used in toys.

                     (5)

                     The Expert Group on Toys Safety recalled, at its meeting on 13 September 2019 (4), that an allergenic substance, whether present in cosmetic products or in toys, is always allergenic. That so-called intrinsic property of the substance is independent from the use of the substance and is therefore present irrespective of whether the allergenic substance is used in cosmetics or in toys. Consequently, the Expert Group considered that an allergenic substance presenting a risk in cosmetic products could equally present a risk in toys. It therefore underlined the importance to take thorough account of the opinions of the SCCS and of its predecessor committees on allergenic fragrances in cosmetic products when regulating allergenic fragrances in toys.

                     (6)

                     Directive 2009/48/EC allows the Commission to prohibit or to require labelling of allergenic fragrances in toys. Contrary to Regulation (EC) No 1223/2009 of the European Parliament and of the Council (5), which regulates cosmetic products, it does not allow the Commission to set maximum limits for allergenic fragrances.

                     (7)

                     In its opinion of 26 and 27 June 2012 the SCCS concluded that cosmetic products containing atranol or chloroatranol are not safe. The SCCS thus confirmed the opinion of the Scientific Committee on Consumer Products (SCCP) of 7 December 2004 (6) that atranol and chloroatranol should not be present in consumer products. The subgroup Chemicals therefore recommended, at its meeting on 3 May 2018 (7), to prohibit the use of atranol and chloroatranol in toys, by adding them to the table in the first paragraph of point 11 of Part III of Annex II to Directive 2009/48/EC.

                     (8)

                     In its opinion of December 1999 (8), the Scientific Committee on Cosmetic Products and non-food Products intended for Consumers (SCCNFP), which was a predecessor of the SCCS, included methyl heptine carbonate among the fragrance chemicals less frequently reported as contact allergens. On the basis of that opinion, methyl heptine carbonate was included among the allergenic fragrances that have to be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, in accordance with the third paragraph of point 11 of Part III of Annex II to Directive 2009/48/EC. In its opinion of 25 September 2001 (9), the SCCNFP recommended that the level of methyl heptine carbonate in finished cosmetic products should not exceed 0,01 %.

                     (9)

                     Considering the above, and in particular the SCCS opinion concluding that cosmetic products containing atranol or chloroatranol are not safe, the SCCP opinion that atranol and chloroatranol should not be present in consumer products and the SCCNFP opinion that methyl heptine carbonate should not exceed 0,01 % in cosmetic products, the Expert Group on Toys Safety recommended, at its meeting on 13 September 2019, to prohibit the use of atranol, chloroatranol and methyl heptine carbonate in toys.

                     (10)

                     In light of the opinions of the SCCS, the SCCP and the SCCNFP, and of the recommendation of the Expert Group on Toys Safety the use of atranol, chloroatranol and methyl heptine carbonate in toys should be prohibited.

                     (11)

                     Directive 2009/48/EC should therefore be amended accordingly.

                     (12)

                     The measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 47(1) of Directive 2009/48/EC,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Annex II to Directive 2009/48/EC is amended in accordance with the Annex to this Directive.

            Article 2

               1.   Member States shall adopt and publish, by 4 July 2022 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 5 July 2022.
               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, 11 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 170, 30.6.2009, p. 1.

            (2)  SCCS opinion on fragrance allergens in cosmetic products, 26 – 27 June 2012 (SCCS/1459/11). http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_102.pdf

            (3)  Ministry of Environment and Food of Denmark – Environmental Protection Agency. Survey of allergenic substances in products targeted children – toys and cosmetic products. Survey of Chemical Substances in Consumer Products No 148, 2016.
         https://www2.mst.dk/Udgiv/publications/2016/08/978-87-93529-00-7.pdf

            (4)  Minutes of the meeting of the Expert Group on Toys Safety of 13 September 2019
         https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=17996

            (5)  Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

            (6)  SCCP opinion on atranol and chloroatranol present in natural extracts (e.g. oak moss and tree moss extract), 7 December 2004 (SCCP/00847/04).
         https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_006.pdf

            (7)  Minutes of the Meeting of the Subgroup ‘Chemicals’ of the Expert Group on Toy Safety of 3 May 2018.
         https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeetingDoc&docid=19025

            (8)  Opinion concerning Fragrance Allergy in Consumers – A review of the problem. Analysis of the need for appropriate consumer information and identification of consumer allergens, 8 December 1999 (SCCNFP/0017/98 Final), Table 6b, p. 23.
         https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out98_en.pdf

            (9)  Opinion concerning An initial List of Perfumery Materials which must not form Part of Cosmetic Products except subject to the Restrictions and Conditions laid down, 25 September 2001 (SCCNFP/0392/00 final), p. 8.
         https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out150_en.pdf

            ANNEX
            In Part III of Annex II, point 11 is amended as follows:

                        (1)

                        in the first paragraph, in the table, the following entries are added:

                                    No

                                    Name of the allergenic fragrance

                                    CAS number

                                    ‘(56)

                                    Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde)

                                    526-37-4

                                    (57)

                                    Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde)

                                    57074-21-2

                                    (58)

                                    Methyl heptine carbonate

                                    111-12-6’

                        (2)

                        in the third paragraph, in the table, entry 10 is deleted.


title: Commission Implementing Directive (EU) 2021/415 of 8 March 2021 amending Council Directives 66/401/EEC and 66/402/EEC in order to adapt to the evolution of scientific and technical knowledge, taxonomic groups and names of certain species of seeds and weeds (Text with EEA relevance)

text:
                  9.3.2021

                  EN

                  Official Journal of the European Union

                  L 81/65

         COMMISSION IMPLEMENTING DIRECTIVE (EU) 2021/415
         of 8 March 2021
         amending Council Directives 66/401/EEC and 66/402/EEC in order to adapt to the evolution of scientific and technical knowledge, taxonomic groups and names of certain species of seeds and weeds
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), and in particular Article 2(1)(A)(a) and Article 21a thereof,
         Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (2), and in particular Article 2(1)(A) and Article 21a thereof,
         Whereas:

                     (1)

                     In the light of the development of scientific knowledge, the botanical names of hard fescue and of couch grass, as well as the botanical names of wheat, durum wheat, spelt wheat, sorghum and Sudan grass have been revised in accordance with the rules of the International Code of Nomenclature for algae, fungi, and plants.

                     (2)

                     The botanical name of hard fescue was revised since the name Festuca trachyphylla (Hack.) Hack. was published validly earlier than the name Festuca trachyphylla (Hack.) Krajina. Elytrigia repens as the botanical name of couch grass was not published validly. Instead, Elymus repens has been established as the valid botanical name of that species.

                     (3)

                     Genome- and phylogeny-based approaches to the taxonomy of Triticum species have confirmed that durum wheat and spelt wheat, previously considered independent species, are subspecies of other species. The previous botanical name of durum wheat, Triticum durum Desf., therefore has been revised and the new name is Triticum turgidum L. subsp. durum (Desf.) van Slageren. The botanical name of spelt wheat, Triticum spelta L., has been revised and now is Triticum aestivum L. subsp. spelta (L.) Thell. As a consequence of spelt wheat becoming a subspecies of wheat, the plant grouping previously named Triticum aestivum L. has been renamed Triticum aestivum L. subsp. aestivum in accordance with the rules of the International Code of Nomenclature for algae, fungi, and plants.

                     (4)

                     The previous botanical name of Sudan grass, Sorghum sudanense (Piper) Stapf, was not published validly and Sorghum bicolor (L.) Moench subsp. drummondii (Steud.) de Wet ex Davidse has been established as the valid botanical name of this plant grouping in accordance with the rules of the International Code of Nomenclature for algae, fungi, and plants. As a consequence of Sudan grass having the taxonomic rank of a subspecies of sorghum, the botanical name of sorghum, Sorghum bicolor (L.) Moench, has been revised in accordance with the rules of the International Code of Nomenclature for algae, fungi, and plants and now is Sorghum bicolor (L.) Moench subsp. bicolor.

                     (5)

                     Directives 66/401/EEC and 66/402/EEC should therefore be amended in order to reflect those changes.

                     (6)

                     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
            Amendments to Directive 66/401/EEC
            Directive 66/401/EEC is amended as follows:

                        (1)

                        in Αrticle 2(1)(A)(a), the 16th definition is replaced by the following:

                                    ‘Festuca trachyphylla (Hack.) Hack.

                                    Hard fescue’

                        (2)

                        Annex II is amended in accordance with Part A of the Annex to this Directive.

            Article 2
            Amendments to Directive 66/402/EEC
            Directive 66/402/EEC is amended as follows:

                        (1)

                        Article 2(1)(A) is amended as follows:

                                    (a)

                                    the eighth definition is replaced by the following:

                                                ‘Sorghum bicolor (L.) Moench subsp. bicolor

                                                Sorghum’

                                    (b)

                                    the ninth definition is replaced by the following:

                                                ‘Sorghum bicolor (L.) Moench subsp. drummondii (Steud.) de Wet ex Davidse

                                                Sudan grass’

                                    (c)

                                    the 11th definition is replaced by the following:

                                                ‘Triticum aestivum L. subsp. aestivum

                                                Wheat’

                                    (d)

                                    the 12th definition is replaced by the following:

                                                ‘Triticum turgidum L. subsp. durum (Desf.) van Slageren

                                                Durum wheat’

                                    (e)

                                    the 13th definition is replaced by the following:

                                                ‘Triticum aestivum L. subsp. spelta (L.) Thell.

                                                Spelt wheat’

                                    (f)

                                    the 15th definition is replaced by the following:

                                                ‘Sorghum bicolor (L.) Moench subsp. bicolor x Sorghum bicolor (L.) Moench subsp. drummondii (Steud.) de Wet ex Davidse

                                                Hybrids resulting from the crossing of Sorghum bicolor (L.) Moench subsp. bicolor and Sorghum bicolor (L.) Moench subsp. drummondii (Steud.) de Wet ex Davidse’

                        (2)

                        Annexes I, II and III are amended in accordance with Part B of the Annex to this Directive.

            Article 3
            Transposition

               1.   Member States shall adopt and publish, by 31 January 2022 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 1 February 2022.
               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 4
            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 5
            Addressees
            This Directive is addressed to the Member States.

            Done at Brussels, 8 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ 125, 11.7.1966, p. 2298.

            (2)  OJ 125, 11.7.1966, p. 2309.

            ANNEX

               Part A – Amendments to Annex II to Directive 66/401/EEC

            The heading of column 7 in the table in point I(2)(A), and the heading of column 5 in the table in point II(2)(A) are replaced by the following:

               ‘Elymus repens’

               Part B – Amendments to Annexes I, II and III to Directive 66/402/EEC

                        (1)

                        Annex I is amended as follows:

                                    (a)

                                    in point 2, footnote (*) to the table is replaced by the following:

                                                ‘(*)

                                                In the areas where the presence of S. halepense or S. bicolor subsp. drummondii is a particular cross-pollination issue, the following shall apply:

                                                            (a)

                                                            crops to produce basic seed of Sorghum bicolor subsp. bicolor or its hybrids must be isolated not less than 800 m from any source of such contaminating pollen;

                                                            (b)

                                                            crops to produce certified seed of Sorghum bicolor subsp. bicolor or its hybrids must be isolated not less than 400 m from any source of such contaminating pollen.’;

                                    (b)

                                    point 5 is replaced by the following:

                                                ‘5.

                                                Crops to produce certified seed of hybrids of Avena nuda, Avena sativa, Avena strigosa, Oryza sativa, Triticum aestivum subsp. aestivum, Triticum turgidum subsp. durum, Triticum aestivum subsp. spelta and self-pollinating xTriticosecale and crops to produce certified seed of hybrids of Hordeum vulgare by means of a technique other than Cytoplasmic Male Sterility (CMS)

                                                            (a)

                                                            The crop shall conform to the following standards as regards distances from neighbouring sources of pollen which may result in undesirable foreign pollination:

                                                                        —

                                                                        the minimum distance of the female component shall be 25 m from any other variety of the same species except from a crop of the male component,

                                                                        —

                                                                        this distance can be disregarded if there is sufficient protection from any undesirable foreign pollination;

                                                            (b)

                                                            The crop shall have sufficient identity and purity as regards the characteristics of the components.
                                                            Where seed is produced by use of a chemical hybridisation agent, the crop shall conform to the following other standards or conditions:

                                                                        (i)

                                                                        the minimum varietal purity of each component shall be:

                                                                                —

                                                                                Avena nuda, Avena sativa, Avena strigosa, Hordeum vulgare, Oryza sativa, Triticum aestivum subsp. aestivum, Triticum turgidum subsp. durum and Triticum aestivum subsp. spelta: 99,7 %,

                                                                                —

                                                                                self-pollinating xTriticosecale: 99,0 %;

                                                                        (ii)

                                                                        the minimum hybridity must be 95 %. The percentage hybridity shall be assessed in accordance with current international methods, in so far as such methods exist. In cases where the hybridity is determined during seed testing prior to certification, the determination of the hybridity during field inspection need not be done.’;

                                    (c)

                                    point 7(B)(a) is replaced by the following:

                                                ‘(a)

                                                for Avena nuda, Avena sativa, Avena strigosa, Hordeum vulgare, Oryza sativa, Phalaris canariensis, xTriticosecale, Triticum aestivum subsp. aestivum, Triticum turgidum subsp. durum, Triticum aestivum subsp. spelta, Secale cereale: one;’;

                        (2)

                        Annex II is amended as follows:

                                    (a)

                                    point 1 is amended as follows:

                                                (i)

                                                point (A) is replaced by the following:

                                                            ‘A.

                                                                  Avena nuda, Avena sativa, Avena strigosa, Hordeum vulgare, Oryza sativa, Triticum aestivum subsp. aestivum, Triticum turgidum subsp. durum, Triticum aestivum subsp. spelta other than hybrids in each case:

                                                                        Category

                                                                        Minimum varietal purity
                                                                        (%)

                                                                        Basic seed

                                                                        99,9

                                                                        Certified seed, 1st generation

                                                                        99,7

                                                                        Certified seed, 2nd generation

                                                                        99,0

                                                                  The minimum varietal purity shall be examined mainly in field inspections carried out in accordance with the conditions laid down in Annex I.’;

                                                (ii)

                                                point (C) is replaced by the following:

                                                            ‘C.

                                                               Hybrids of Avena nuda, Avena sativa, Avena strigosa, Hordeum vulgare, Oryza sativa, Triticum aestivum subsp. aestivum, Triticum turgidum subsp. durum, Triticum aestivum subsp. spelta, and self-pollinating xTriticosecale

                                                            The minimum varietal purity of the seed of the category certified seed shall be 90 %.
                                                            In case of Hordeum vulgare produced by means of CMS, it shall be 85 %. Impurities other than the restorer shall not exceed 2 %.
                                                            The minimum varietal purity shall be examined in official post-control test on an appropriate proportion of samples.’;

                                    (b)

                                    in the table of point 2(A), the entry in the third row of column 1 is replaced by the following:
                                    ‘Avena sativa, Avena strigosa, Hordeum vulgare, Triticum aestivum subsp. aestivum, Triticum turgidum subsp. durum, Triticum aestivum subsp. spelta:’;

                        (3)

                        in Annex III the table is amended as follows:

                                    (i)

                                    in the third row in the first column, the entry is replaced by the following:
                                    ‘Avena sativa, Avena strigosa, Hordeum vulgare, Triticum aestivum subsp. aestivum, Triticum turgidum subsp. durum, Triticum aestivum subsp. spelta, Secale cereale, xTriticosecale’;

                                    (ii)

                                    in the sixth row in the first column, the entry is replaced by:
                                    ‘Sorghum bicolor (L.) Moench subsp. bicolor’;

                                    (iii)

                                    in the seventh row in the first column, the entry is replaced by:
                                    ‘Sorghum bicolor (L.) Moench subsp. drummondii (Steud.) de Wet ex Davidse’;

                                    (iv)

                                    in the eighth row in the first column, the entry is replaced by:
                                    ‘Hybrids of Sorghum bicolor (L.) Moench subsp. bicolor x Sorghum bicolor (L.) Moench subsp. drummondii (Steud.) de Wet ex Davidse’.


title: Commission Delegated Directive (EU) 2021/1716 of 29 June 2021 amending Directive 2014/47/EU of the European Parliament and of the Council as regards modifications to the vehicle category designations stemming from amendments to the type-approval legislation (Text with EEA relevance)

text:
                  27.9.2021

                  EN

                  Official Journal of the European Union

                  L 342/45

         COMMISSION DELEGATED DIRECTIVE (EU) 2021/1716
         of 29 June 2021
         amending Directive 2014/47/EU of the European Parliament and of the Council as regards modifications to the vehicle category designations stemming from amendments to the type-approval legislation
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2014/47/EU of the European Parliament and of the Council of 3 April 2014 on the technical roadside inspection of the roadworthiness of commercial vehicles circulating in the Union and repealing Directive 2000/30/EC (1) and in particular Article 21 thereof,
         Whereas:

                     (1)

                     Directive 2014/47/EU applies to commercial vehicles with a design speed exceeding 25km/h of the categories listed in Article 2(1) of that Directive. Those categories are determined by reference to Directives 2003/37/EC (2) and 2007/46/EC (3) of the European Parliament and of the Council.

                     (2)

                     Directives 2003/37/EC and 2007/46/EC were repealed, respectively, by Regulation (EU) No 167/2013 (4), and Regulation (EU) 2018/858 (5) of the European Parliament and of the Council.

                     (3)

                     Given the changes to the vehicle category designations that stemmed from the repeal of Directive 2003/37/EC by Regulation (EU) No 167/2013, the vehicle categories referred to in Article 2(1) of Directive 2014/47/EU, as well as point 6 of Annex IV to that Directive, should be updated.

                     (4)

                     Directive 2014/47/EU should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Directive 2014/47/EU is amended as follows:

                        (1)

                        Article 2 is amended as follows:

                                    (a)

                                    paragraph 1 is amended as follows:

                                                (i)

                                                the introductory wording is replaced by the following:

                                                   ‘1.   This Directive shall apply to vehicles with a design speed exceeding 25 km/h of the following categories, as defined in Regulation (EU) No 167/2013 of the European Parliament and of the Council (*1), and Regulation (EU) 2018/858 of the European Parliament and of the Council (*2):

                                                   (*1)  Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1)."

                                                   (*2)  Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).’;"

                                                (ii)

                                                point (d) is replaced by the following:

                                                            ‘(d)

                                                            vehicles of categories T1b, T2b, T3b, T4.1b, T4.2b and T4.3b the use of which mainly takes place on public roads for commercial road haulage purposes, with a maximum design speed exceeding 40 km/h.’;

                        (2)

                        in Annex IV, point 6 is amended as follows:

                                    (a)

                                    points (g) and (h) are replaced by the following:

                                                ‘(g)

                                                T1b;

                                                (h)

                                                T2b;’;

                                    (b)

                                    the following points (i) to (m) are added:

                                                ‘(i)

                                                T3b;

                                                (j)

                                                T4.1b;

                                                (k)

                                                T4.2b;

                                                (l)

                                                T4.3b;

                                                (m)

                                                Other vehicle category:
                                                (please specify).’.

            Article 2
            Transposition

               1.   Member States shall adopt and publish, by 27 September 2022 at the latest, the laws, regulations and administrative measures necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
               They shall apply the measures necessary to comply with Article 1 from 27 September 2022.
               When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.

               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
            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, 29 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 127, 29.4.2014, p. 134.

            (2)  Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC (OJ L 171, 9.7.2003, p. 1).

            (3)  Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (OJ L 263, 9.10.2007, p. 1).

            (4)  Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).

            (5)  Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).