title: COMMISSION IMPLEMENTING REGULATION (EU) …/... concerning the denial of authorisation of formaldehyde as a feed additive belonging to the functional groups of preservatives and hygiene condition enhancers

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 7.2.2018

               concerning the denial of authorisation of formaldehyde as a feed additive belonging to the functional groups of preservatives and hygiene condition enhancers

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

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

               Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition
                  1
               , and in particular Article 9(2) thereof,

               Whereas:

               (1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or denying such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC
                  2
               .

               (2)Formaldehyde was authorised for an unlimited period in accordance with Directive 70/524/EEC as a feed additive belonging to the group of preservatives for pigs up to six months of age for use in skimmed milk by Commission Directive 83/466/EEC
                  3
               . That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

               (3)Formaldehyde (EC No 200-001-8, CAS No 50-00-0) was included in the list, established by Commission Regulation (EC) No 1451/2007
                  4
               , of active substances to be assessed with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council
                  5
               . However, Regulation (EU) No 528/2012 of the European Parliament and of the Council
                  6
               , replacing Directive 98/8/EC, does not cover products used for the preservation of feed by controlling harmful organisms, in particular for reducing the contamination of feed with Salmonella, considering that such products fall within the scope of Regulation (EC) No 1831/2003. Since 1 July 2015, in accordance with Commission Decision 2013/204/EU
                  7
               , biocidal products for use as feed preservatives and containing formaldehyde are not to be placed on the market. That date was set with the aim to provide the time necessary to allow the transition from the biocidal products regulatory regime to the feed additives regime under Regulation (EC) No 1831/2003.

               (4)In accordance with Article 7 of Regulation (EC) No 1831/2003, two applications were submitted for the authorisation of a preparation of formaldehyde as a feed additive for all animal species, requesting the additive to be classified in the additive category "technological additives" and in the functional group "preservatives". Both applications include the use in skimmed milk for pigs up to the age of six months, as an existing product, in accordance with Article 10(2) of Regulation (EC) No 1831/2003. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (5)In addition, in accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of formaldehyde as a feed additive for pigs and poultry, requesting the additive to be classified in the additive category "technological additives" and in the functional group "hygiene condition enhancers". This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (6)The European Food Safety Authority ('the Authority') concluded in its two opinions of 28 January 2014
                  8
                and in its opinion of 1 July 2014
                  9
                that, as regards the target species, the preparation of formaldehyde would be safe at specific concentration levels for chickens for fattening, laying hens, Japanese quail and piglets (weaned) but that no safe level for all animal species and categories, including all poultry and pigs, could be determined. In addition, a formaldehyde concentration level that would be safe for reproduction for the target species could not be derived from the available studies. The Authority also concluded that the preparation of formaldehyde had the potential to be effective as preservative and, as hygiene condition enhancer, in reducing microbial growth in feed contaminated with Salmonella. In those three opinions, the Authority further concluded that formaldehyde raised concerns for the safety of the users. Formaldehyde is a toxic substance, a strong irritant, a potent skin and respiratory sensitiser (including occupational asthma) and causes eye damage. In its opinions, the Authority mentioned that, while local irritation is expected to strongly promote carcinogenesis, lower local concentrations of formaldehyde are known to produce DNA adducts and that therefore it deemed it prudent not to consider the exposure to non-irritant concentration as totally risk free. The Authority concluded that moreover, on the basis of the present knowledge, a causal association between formaldehyde exposure and leukaemia could not be ruled out. The Authority concluded that, as regards the requested use in feed of the preparation of formaldehyde, no safe level of exposure of the skin, eyes or the respiratory system to formaldehyde could be identified. Therefore, the Authority recommended that measures should be taken to ensure that the respiratory tract, as well as the skin and eyes, of any person handling the product are not exposed to any dust, mist or vapour generated by the use of formaldehyde. In addition, the Authority recommended that consideration should be given to whether the strict protection measures, once established, would effectively protect users.  The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

               (7)Formaldehyde is classified as carcinogenic (category 1B) by inhalation and germ cell mutagenic (category 2) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council
                  10
               .

               (8)In the framework of Union legislation on health and safety at work, occupational exposure limits are being developed for formaldehyde. The Scientific Committee on Occupational Exposure Limits established by Commission Decision 2014/113/EU
                  11
                has, in its Recommendation of 30 June 2016
                  12
               , pronounced itself on a limit value for formaldehyde based on a mode-of-action assessment, which was then considered by the tripartite Advisory Committee on Safety and Health at Work
                  13
                in accordance with the procedures for establishing occupational exposure limits.

               (9)In accordance with Article 9 of Regulation (EC) No 1831/2003, the measure on the authorisation of an additive is to take into account the requirements of paragraphs 2 and 3 of Article 5 of that Regulation, as well as Community law and other legitimate factors relevant to the matter under consideration. The risk management decision concerning the authorisation of formaldehyde as a feed additive should therefore be based on all the information available regarding the risks at stake, in particular on the one hand the risks posed by the handling of formaldehyde to users, in particular workers, and on the other hand the risks to animals or to consumers of the animal products concerned that could derive from not using formaldehyde as a feed additive.

               (10)In accordance with Union legislation on health and safety at work, and in particular with Article 4 of Directive 2004/37/EC of the European Parliament and of the Council
                  14
               , the employer is to reduce the use of a carcinogen or mutagen at the place of work, in particular by replacing it, in so far as is technically possible, by a substance, mixture or process which, under its conditions of use, is not dangerous or is less dangerous for workers' health or safety.

               (11)Due to the serious risks for users posed by the handling of formaldehyde, such approach based on replacement is also appropriate for that additive, taking into account the objective of ensuring a high level of protection of human health and users' interests pursued by Regulation (EC) No 1831/2003 and the precautionary principle provided for in Regulation (EC) No 178/2002 of the European Parliament and of the Council
                  15
               .

               (12)As regards possible alternative products to formaldehyde as an additive belonging to the functional group of preservatives, a series of additives are currently authorised in the Union under the same functional group.

               (13)As regards possible alternative products to formaldehyde as an additive belonging to the functional group of hygiene condition enhancers
                  16
               , research is currently being conducted to develop additives which would prove both safe and efficacious in reducing microbiological contamination in feed. An additive has already been authorised
                  17
                under that functional group and is therefore considered as an alternative, although with a different mechanism of action, in order to reduce the number of bacterial pathogens, including Salmonella spp, in feed, without causing the concerns over users' safety raised by the use of formaldehyde. Several applications for authorisation of other additives under that functional group have been submitted and are being assessed in accordance with Regulation (EC) No 1831/2003. In addition, other authorised feed additives may, as zootechnical additives, improve the quality of animal products through a reduction of contamination with enteropathogens such as Salmonella spp.

               (14)In addition to the possibility of using alternative products to formaldehyde for the envisaged purposes in feed, the implementation of the hygiene requirements and good practices along the feed chain, as provided for in Regulation (EC) No 183/2005 of the European Parliament and of the Council
                  18
               , contributes to the safety and quality of feed through a preventive approach. In particular, specific hygiene measures are provided for under that framework for the control, prevention and treatment of feed contaminated with Salmonella.

               (15)It follows from the above elements that, taking into account the adverse effects of formaldehyde on the health of users handling the substance, in conjunction with the application of the precautionary principle in the protection of workers' health and with the fact that some products and measures, which do not present the same human safety concerns, are available as alternatives to the envisaged uses of formaldehyde in feed, the advantages of formaldehyde do not compensate the health risks. Therefore, the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are not satisfied and accordingly, the authorisation of formaldehyde as a feed additive for use as preservative and hygiene condition enhancer should be denied.

               (16)Since further use of formaldehyde may cause a risk to human health, the feed additive belonging to the functional group of "preservatives" for use in skimmed milk for pigs up to the age of six months, and premixtures containing it, should be withdrawn from the market as soon as possible. For practical reasons however, a limited period should be allowed for the withdrawal from the market of the existing stocks of those products in order to enable operators to comply properly with the withdrawal obligation. As a result, a limited period should also be granted for the withdrawal from the market of skimmed milk containing the additive or the premixtures, and compound feed containing such skimmed milk, in order to take into account the use of those products in the feed chain.

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

               HAS ADOPTED THIS REGULATION:

               Article 1
                  Denial of authorisation

               The authorisation of formaldehyde as an additive in animal nutrition, belonging to the additive category "technological additives" and to the functional groups "preservatives" and "hygiene condition enhancers", is denied.

               Article 2
                  Withdrawal from the market

               1.Existing stocks of formaldehyde as an additive belonging to the additive category "technological additives" and to the functional group "preservatives" for use in skimmed milk for pigs up to the age of six months, and of premixtures containing that additive, shall be withdrawn from the market as soon as possible and at the latest by [3 months from the date of entry into force of this Regulation – Date to be inserted by the Service responsible for the publication].

               2.Skimmed milk containing the additive or skimmed milk containing the premixtures referred to in paragraph 1, and compound feed containing such skimmed milk, which have been produced before [3 months from the date of entry into force of this Regulation – Date to be inserted by the Service responsible for the publication] shall be withdrawn from the market as soon as possible and at the latest by [6 months from the date of entry into force of this Regulation – Date to be inserted by the Service responsible for the publication].

               Article 3
                  Entry into force

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

               This Regulation shall be binding in its entirety and directly applicable in all Member States.

               Done at Brussels, 7.2.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 268, 18.10.2003, p. 29.

                     (2)

                        Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

                     (3)

                        Forty-third Commission Directive 83/466/EEC of 28 July 1983 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (OJ L 255, 15.9.1983, p. 28). The chemical description of the additive was made more precise by Commission Directive 85/429/EEC of 8 July 1985 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (OJ L 245, 12.9.1985, p. 1).

                     (4)

                        Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

                     (5)

                        Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

                     (6)

                        Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market of biocidal products (OJ L 167, 27.6.2012, p. 1).

                     (7)

                        Commission Decision 2013/204/EU of 25 April 2013 concerning the non-inclusion of formaldehyde for product-type 20 in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 117, 27.4.2013, p. 18).

                     (8)

                        EFSA Journal 2014;12(2):3561 and EFSA Journal 2014;12(2)3562.

                     (9)

                        EFSA Journal 2014;12(7):3790.

                     (10)

                        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).

                     (11)

                        Commission Decision 2014/113/EU of 3 March 2014 on setting up a Scientific Committee on Occupational Exposure Limits for Chemical Agents and repealing Decision 95/320/EC (OJ L 62, 4.3.2014).

                     (12)

                        SCOEL/REC/125. Available at the following address:

                  https://publications.europa.eu/en/publication-detail/-/publication/7a7ae0c9-c03d-11e6-a6db-01aa75ed71a1

                     (13)

                        The Advisory Committee on Safety and Health at Work was established by Council Decision 2003/C 218/01 of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work (OJ C 218, 13.9.2003, p. 1).

                     (14)

                        Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).

                     (15)

                        Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

                     (16)

                        This functional group has been established as a result of technological and scientific development by Commission Regulation (EU) 2015/2294 of 9 December 2015 amending Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the establishment of a new functional group of feed additives (OJ L 324, 10.12.2015, p. 3).

                     (17)

                        Commission Implementing Regulation (EU) 2017/940 of 1 June 2017 concerning the authorisation of formic acid as a feed additive for all animal species (OJ L 142, 2.6.2017, p. 40).

                     (18)

                        Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).


title: COMMISSION IMPLEMENTING REGULATION (EU) …/... on uniform conditions for the transmission of time series for the new regional breakdown pursuant to Regulation (EC) No 1059/2003

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 8.11.2018

               on uniform conditions for the transmission of time series for the new regional breakdown pursuant to Regulation (EC) No 1059/2003

               THE EUROPEAN COMMISSION,

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

               Having regard to Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS)
                  1
               , and in particular Article 5(5) thereof,

               Whereas:

               (1)Regulation (EC) No 1059/2003 provides the legal framework for the regional classification in order to enable the collection, compilation and dissemination of harmonised regional statistics in the Union.

               (2)The Commission has amended the common classification of territorial units for statistics (NUTS) by Regulation (EU) 2016/2066 with effect from 1 January 2018.

               (3)The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee,

               HAS ADOPTED THIS REGULATION:

               Article 1

               Member States shall transmit to the Commission the time series for the new regional breakdown in accordance with the Annex.

               Article 2

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

               This Regulation shall be binding in its entirety and directly applicable in all Member States.

               Done at Brussels, 8.11.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 154, 21.6.2003, p. 1 as last amended by Regulation (EU) 2017/2391 (OJ L 350, 29.12.2017, p. 1).

    ---documentbreak---

               ANNEX

               Required starting year by statistical domain

                        Domain

                        NUTS level 2

                        NUTS level 3

                        Agriculture

                        2013

                        Demography – population, live births, deaths

                        1990
                           1

                        1990
                           2

                        Labour market - employment, unemployment

                        2013

                        2013
                           3

                        Education

                        2013

                        Environment –  waste treatment facilities

                        2014

                        Health – causes of death

                        1997
                           4

                        Health – infrastructure

                        1996
                           5

                        Health – patients

                        2003
                           6

                        Information society

                        2013
                           7

                        Regional economic accounts: Household accounts

                        2000

                        Regional economic accounts - Regional accounts

                        2000

                        2000

                        Science and technology - R&D expenditure and staff

                        2015

                        Tourism

                        2015

                     (1)

                        Transmission is not mandatory for reference years 1990 to 2012.

                     (2)

                        Transmission is not mandatory for reference years 1990 to 2012.

                     (3)

                        The transmission is not mandatory.

                     (4)

                        Transmission is not mandatory for reference years 1997 to 2011.

                     (5)

                        The transmission is not mandatory.

                     (6)

                        The transmission is not mandatory.

                     (7)

                        The transmission is not mandatory.


title: COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards analysis methods for determining the physical, chemical and organoleptic characteristics of grapevine products and notifications of Member States decisions concerning increases in natural alcoholic strength

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 16.4.2019

               laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards analysis methods for determining the physical, chemical and organoleptic characteristics of grapevine products and notifications of Member States decisions concerning increases in natural alcoholic strength

               THE EUROPEAN COMMISSION,

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

               Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007
                  1
                and in particular Articles 80(5), 91(c) and (d) and 223(3) thereof,

               Whereas:

               (1)Regulation (EU) No 1308/2013 repealed and replaced Council Regulation (EC) No 1234/2007
                  2
               . Section 1 of Chapter I of Title II of Part II of Regulation (EU) No 1308/2013 lays down rules on the categories of grapevine products, oenological practices and the applicable restrictions and empowers the Commission to adopt delegated and implementing acts in that respect. In order to ensure the smooth functioning of the wine market in the new legal framework, certain rules have to be adopted by means of such acts. Those acts should replace the provisions of Commission Regulation (EC) No 606/2009
                  3
                which is repealed by Commission Delegated Regulation (EU)
                  4
                [oenological Delegated Regulation].

               (2)Pursuant to Article 80(5) and Article 91(d) of Regulation (EU) No 1308/2013 the Commission shall, where necessary, lay down rules on the analysis methods for determining the physical, chemical and organoleptic characteristics of grapevine products. The methods shall be based on any relevant methods recommended and published by the International Organisation of Vine and Wine (OIV), unless they would be ineffective or inappropriate. Article 91(c) of Regulation (EU) No 1308/2013 moreover empowers the Commission to lay down rules for checking whether those products have been subjected to processes contrary to the authorised oenological practices in the Union.

               (3)The method of analysis for determining whether allyl isothiocyanate is present in the wine product is laid down in the Annex to this Regulation. As regards other methods for determining whether products have undergone processes contrary to the authorised oenological practices, the applicable rules should be those allowed by the Member States concerned.

               (4)Point 3 of Section A of Part I of Annex VIII to Regulation (EU) No 1308/2013 sets out an obligation for Member States to notify the Commission of any increase in the limits laid down in point 2 of that Section. Details concerning the submission of this information by Member States to the Commission should be laid down.

               (5)The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

               HAS ADOPTED THIS REGULATION:

               Article 1
               Scope

               This Regulation lays down rules for the application of Title II, Chapter I of Regulation (EU) No 1308/2013, concerning analysis methods for determining the physical, chemical and organoleptic characteristics of grapevine products, and notifications of decisions by Member States allowing increases in natural alcoholic strength.

               Article 2
               Applicable Union analysis methods

               The analysis methods referred to in point (d) of Article 75(5) of Regulation (EU) No 1308/2013 to be used for verification of the limits laid down by Union rules to the use of allyl isothiocyanate for the production of certain grapevine products are laid down in the Annex to this Regulation.

               Article 3
               Notification of Member States decisions allowing an increase in natural alcoholic strength

               1. Member States allowing for an increase of the natural alcoholic strength by volume pursuant to point 3 of Section A of Part I of Annex VIII of Regulation (EU) No 1308/2013 shall notify the Commission of this within one month following the granting of the derogation. In the notification, the Member States shall specify the regions and the varieties concerned by the decision and they shall submit data and evidence indicating that the climatic conditions have been exceptionally unfavourable in the regions concerned.

               2. The notification shall be made in accordance with Delegated Regulation (EU) 2017/1183
                  5
                and Commission Implementing Regulation (EU) 2017/1185
                  6
               .

               3. The Commission shall then inform the other Member States.

               Article 4
               Entry into force

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

               It shall apply from [to be aligned with the date of application of the DA].

               This Regulation shall be binding in its entirety and directly applicable in all Member States.

               Done at Brussels, 16.4.2019

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 347, 20.12.2013, p. 671.

                     (2)

                        Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organization of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (OJ L 299, 16.11.2007, p. 1).

                     (3)

                        Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down certain detailed rules for implementing Council Regulation (EC) No 479/2008 as regards the categories of grapevine products, oenological practices and the applicable restrictions (OJ L 193, 24.7.2009, p. 1).

                     (4)

                        Commission Delegated Regulation (EU) …/… of […] [...] (OJ L […]).

                     (5)

                        Commission Delegated Regulation (EU) 2017/1183 of 20 April 2017 on supplementing Regulations (EU) No 1307/2013 and (EU) No 1308/2013 of the European Parliament and of the Council with regard to the notifications to the Commission of information and documents (OJ L 171, 4.7.2017, p. 100).

                     (6)

                        Commission Implementing Regulation (EU) 2017/1185 of 20 April 2017 laying down rules for the application of Regulations (EU) No 1307/2013 and (EU) No 1308/2013 of the European Parliament and of the Council as regards notifications to the Commission of information and documents and amending and repealing several Commission Regulations (OJ L 171, 4.7.2017, p. 113).

    ---documentbreak---

               EN

               ANNEX

               SPECIAL UNION ANALYSIS METHODS

               ALLYL ISOTHIOCYANATE

               1. Principle of the method

               Any allyl isothiocyanate present in the wine is collected by distillation and identified by gas chromatography.

               2. Reagents

               2.1. Ethanol, absolute.

               2.2. Standard solution: solution of allyl isothiocyanate in absolute alcohol containing 15 mg of allyl isothiocyanate per litre.

               2.3. Freezing mixture consisting of ethanol and dry ice (temperature – 60 °C).

               3. Apparatus

               3.1. Distillation apparatus as shown in the figure. A stream of nitrogen is passed continuously through the apparatus.

               3.2. Heating mantle, thermostatically controlled.

               3.3. Flowmeter.

               3.4. Gas chromatograph fitted with a flame spectrophotometer detector equipped with a selective filter for sulphur compounds (wavelength = 394 nm) or any other suitable detector.

               3.5. Stainless steel chromatograph column of internal diameter 3 mm and length 3 m filled with Carbowax 20M at 10 % on Chromosorb WHP, 80 to 100 mesh.

               3.6. Microsyringe, 10μl.

               4. Procedure

               Put two litres of wine into the distillation flask, introduce a few millilitres of ethanol (point 2.1) into the two collecting tubes so that the porous parts of the gas dispersion rods are completely immersed. Cool the two tubes externally with the freezing mixture. Connect the flask to the collecting tubes and begin to flush the apparatus with nitrogen at a rate of three litres per hour. Heat the wine to 80 °C with the heating mantle, distil and collect 45 to 50 ml of the distillate.

               Stabilize the chromatograph. It is recommended that the following conditions are used:

               — injector temperature: 200 °C,

               — column temperature: 130 °C,

               — helium carrier gas flow rate: 20 ml per minute.

               With the microsyringe, introduce a volume of the standard solution such that the peak corresponding to the allyl isothiocyanate can easily be identified on the gas chromatogram.

               Similarly introduce an aliquot of the distillate into the chromatograph. Check that the retention time of the peak obtained corresponds with that of the peak of allyl isothiocyanate.

               Under the conditions described above, compounds naturally present in the wine will not produce interfering peaks on the chromatogram of the sample solution.

               Apparatus for distillation under a current of nitrogen


title: COMMISSION IMPLEMENTING REGULATION (EU) …/... concerning the technical requirements regarding the content of quality reports on European statistics on natural gas and electricity prices pursuant to Regulation (EU) 2016/1952 of the European Parliament and of the Council

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 17.5.2019

               concerning the technical requirements regarding the content of quality reports on European statistics on natural gas and electricity prices pursuant to Regulation (EU) 2016/1952 of the European Parliament and of the Council

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

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

               Having regard to Regulation (EU) 2016/1952 of the European Parliament and of the Council of 26 October 2016 on European statistics on natural gas and electricity prices
                  1
               , and in particular Article 7(5) thereof,

               Whereas:

               (1)Regulation (EU) 2016/1952 sets out the framework for producing comparable European statistics on natural gas and electricity prices.

               (2)In accordance with Article 7(3) of Regulation (EU) 2016/1952, every 3 years, Member States are to provide the Commission (Eurostat) with standard quality reports on the data in accordance with the quality criteria laid down in Article 12(1) of Regulation (EC) No 223/2009 of the European Parliament and of the Council
                  2
               . Those reports are to include information on the scope and collection of the data, the calculation criteria, the methodology and data sources used, and any changes thereto.

               (3)In accordance with Article 7(4) of Regulation (EU) 2016/1952, the Commission (Eurostat) is to assess the quality of the data submitted and is to use that assessment and an analysis of the quality reports in order to prepare and publish a report on the quality of European statistics covered by the Regulation (EU) 2016/1952.

               (4)Following the entry into force of Regulation (EU) 2016/1952, the Commission (Eurostat) worked closely with Member States to assess the relevant technical quality assurance requirements regarding the content and the appropriate timing of the quality reports.

               (5)The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee,

               HAS ADOPTED THIS REGULATION:

               Article 1

               (1)The technical quality assurance requirements regarding the content of the quality reports on the data on natural gas and electricity prices are set out in the Annex.

               (2)Member States shall submit the first quality reports by 15 June 2019.

               (3)Each quality report shall cover the full years elapsed since the date of the previous quality report. However, the first quality reports shall cover reference years 2017 and 2018.

               Article 2

               The quality reports shall be provided through the single entry point provided by the Commission (Eurostat) in order to enable the Commission (Eurostat) to receive those quality reports by electronic means.

               Article 3

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

               This Regulation shall be binding in its entirety and directly applicable in all Member States.

               Done at Brussels, 17.5.2019

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 311, 17.11.2016, p. 1.

                     (2)

                        Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).

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               ANNEX

               Technical quality assurance requirements regarding the content of the quality reports
                  of European statistics on natural gas and electricity prices

               The quality reports shall include information on all the quality criteria laid down in Article 12(1) of Regulation (EC) No 223/2009.

               1.RELEVANCE

               Member States shall provide the following information in the quality reports:

               (a)a description of users, their respective needs and a justification of these needs;

               (b)procedures used to measure user satisfaction and produce the results;

               (c)the extent to which the required statistics are available.

               2.ACCURACY

               The quality reports shall contain:

               (a)an accuracy assessment which summarises the various dataset components;

               (b)a description of the sampling errors;

               (c)a description of any other errors.

               3.TIMELINESS AND PUNCTUALITY

               Member States shall report on:

               (a)the length of time between the event or phenomenon they describe and the data availability (timeliness);

               (b)the length of time between the target date for data delivery and the actual data delivery date (punctuality);

               (c)the number of iterations needed in order to have fully validated data (validation iterations).

               4.ACCESSIBILITY AND CLARITY

               Member States shall report on the conditions and means by which users can:

               (a)obtain and use the data (including, but not limited to news releases, publications, online databases, micro data access);

               (b)interpret the data such as providing documentation on methodology and quality management.

               5.COMPARABILITY

               Member States shall report on the extent to which statistics are comparable:

               (a)between geographical areas;

               (b)over time.

               6.COHERENCE

               Member States shall report on the extent to which statistics are:

               (a)reconcilable with data obtained through other sources (cross domain coherence);

               (b)consistent within a given dataset (internal coherence).

               Member States shall also report on the following additional quality aspects:

               1.QUALITY MANAGEMENT:

               Member States shall report on the systems and frameworks in place to manage the quality of statistical products and processes. They shall also report on their assessment of the quality of the data.

               2.DATA REVISION:

               Member States shall explain why validated data have been revised. The reasons may include information of new source of data available, new methods or other relevant information. The report shall also include the date, the size and the magnitude of the revisions.

               In accordance with Article 7(3) of Regulation (EU) 2016/1952, those reports shall include information on the scope and collection of the data, the calculation criteria, the methodology and data sources used, and any changes made.

               1.STATISTICAL PRESENTATION

               Member States shall provide the following description of the disseminated data which can be displayed to users as tables, graphs or maps:

               (a)data description;

               (b)classification system;

               (c)sector coverage;

               (d)statistical concepts and definitions;

               (e)statistical unit;

               (f)statistical population;

               (g)reference area (geographical scope);

               (h)time coverage (length of time for which data are available);

               (i)reference period (period covered by the report);

               (j)unit of measure.

               2.STATISTICAL PROCESSING:

               The quality reports shall cover a description of all procedures used to collect, validate and compile the data and to derive new information.

               3.RELEASE POLICY

               The quality reports shall report on the rules for disseminating the data at national level.

               4.FREQUENCY OF DISSEMINATION

               The reports shall also indicate the frequency with which the data is disseminated at national level.

               In line with the statistical principles laid down in points (e) and (f) of Article 2(1) of Regulation (EC) No 223/2009, Member States shall report on:

               1.CONFIDENTIALITY

               The quality reports shall contain information on the legislative measures or other formal procedures, which prevent any unauthorised disclosure of data that could directly or indirectly cause a person or economic entity to be identified. They will also outline the rules applied to ensure statistical confidentiality and prevent unauthorised disclosure.

               2.COST AND BURDEN:

               The quality reports shall contain information on the cost and burden associated with the collection and production of the statistical product.