title: Commission Implementing Regulation (EU) 2020/1822 of 2 December 2020 authorising the placing on the market of chromium-containing yeast (Yarrowia lipolytica) biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

text:
                  3.12.2020

                  EN

                  Official Journal of the European Union

                  L 406/39

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1822
         of 2 December 2020
         authorising the placing on the market of chromium-containing yeast (Yarrowia lipolytica) biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

                     (3)

                     Commission Implementing Regulation (EU) 2019/760 (3) authorised, in accordance with Regulation (EU) 2015/2283, the placing on the market of Yarrowia lipolytica yeast biomass as a novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4), excluding food supplements for infants and young children.

                     (4)

                     On 22 August 2018, the company Skotan S.A. (‘the applicant’) introduced an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place chromium-enriched biomass of the yeast Yarrowia lipolytica on the Union market as a novel food. The applicant requested for chromium-enriched biomass of the yeast Yarrowia lipolytica to be used as a novel food in food supplements, excluding food supplements for infants and young children. The maximum use levels proposed by the applicant are 2 g per day for children from 3 to 9 years of age, and 4 g per day for adolescents and adults.

                     (5)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘Authority’) on 18 February 2019, asking it to provide a scientific opinion by carrying out an assessment for chromium-containing yeast (Yarrowia lipolytica) biomass as a novel food.

                     (6)

                     On 23 January 2020, the Authority adopted its scientific opinion ‘Safety of chromium-enriched biomass of Yarrowia lipolytica as a novel food pursuant to Regulation (EU) 2015/2283’ (5). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (7)

                     In its opinion, the Authority concluded that chromium-containing yeast (Yarrowia lipolytica) biomass is safe under the proposed uses and use levels, when used in food supplements intended for the general population above 3 years of age.

                     (8)

                     The opinion of the Authority gives sufficient grounds to establish that chromium-containing yeast (Yarrowia lipolytica) biomass under the proposed conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (9)

                     Regulation (EU) 2017/2470 should be therefore amended accordingly.

                     (10)

                     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

               1.   Chromium-containing yeast (Yarrowia lipolytica) biomass as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

               2.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.

            Article 2
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            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, 2 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (3)  Commission Implementing Regulation (EU) 2019/760 of 13 May 2019 authorising the placing on the market of Yarrowia lipolytica yeast biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 125, 14.5.2019, p. 13).

            (4)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

            (5)  EFSA Journal 2020;18(3):6005.

            ANNEX
            The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

                        (1)

                        in Table 1 (Authorised novel foods), the following entry is inserted:

                                    Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    ‘Chromium-containing yeast (Yarrowia lipolytica) biomass

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “chromium-containing yeast (Yarrowia lipolytica) biomass”
                                    The labelling of food supplements containing chromium-containing yeast (Yarrowia lipolytica) biomass shall bear a statement that the food supplements should not be consumed by infants and young children (children under 3 years of age)/children from 3 to 9 years of age (*1).

                                    Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

                                    2 g/day for children from 3 to 9 years of age, resulting in 46 μg of chromium per day
                                    4 g/day for children from 10 years of age, adolescents and adults, resulting in 92 μg of chromium per day

                        (2)

                        in Table 2 (Specifications), the following entry is inserted:

                                    Authorised Novel Food

                                    Specification

                                    ‘Chromium-containing yeast (Yarrowia lipolytica) biomass

                                       Description/Definition:

                                    The novel food is the dried and heat-killed chromium-containing biomass of the yeast Yarrowia lipolytica.
                                    The novel food is produced by fermentation in the presence of chromium chloride followed by a number of purification steps and a heat-killing step of the yeast to ensure the absence of viable Yarrowia lipolytica cells in the novel food.

                                       Characteristics/Composition:

                                                Total chromium: 18–23 μg/g

                                                Chromium (VI): < 10 μg/kg (i.e. limit of detection)

                                                Protein: 40–50 g/100 g

                                                Dietary fibre: 24–32 g/100 g

                                                Sugars: < 2 g/100 g

                                                Fat: 6–12 g/100 g

                                                Total ash: ≤ 15 %

                                                Water: ≤ 5 %

                                                Dry matter: ≥ 95 %

                                       Heavy metals:

                                                Lead: ≤ 3,0 mg/kg

                                                Cadmium: ≤ 1,0 mg/kg

                                                Mercury: ≤ 0,1 mg/kg

                                       Microbiological criteria:

                                                Total aerobic microbial count: ≤ 5 × 103 CFU/g

                                                Total yeast and mould count: ≤ 102 CFU/g

                                                Viable Yarrowia lipolytica cells (*2): < 10 CFU/g (i.e. limit of detection)

                                                Coliforms: ≤ 10 CFU/g

                                                   Salmonella spp.: Absence in 25 g

                                                CFU: colony forming units

               (*1)  Depending on the age group the food supplement is intended for.’

               (*2)  Applicable at all stages after the heat-treatment step to guarantee the absence of viable Yarrowia lipolytica cells and to be first tested immediately after the heat-treatment step. Measures have to be in place to prevent cross-contamination with viable Yarrowia lipolytica cells during packaging and/or storage of the novel food.’


title: Commission Implementing Regulation (EU) 2020/1823 of 2 December 2020 amending Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings (Text with EEA relevance)

text:
                  3.12.2020

                  EN

                  Official Journal of the European Union

                  L 406/43

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1823
         of 2 December 2020
         amending Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings
         (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 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (1), and in particular Article 9(1) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1331/2008 lays down procedural arrangements for updating the lists of substances the marketing of which is authorised in the Union pursuant to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (2), Regulation (EC) No 1332/2008 of the European Parliament and of the Council (3) and Regulation (EC) No 1334/2008 of the European Parliament and of the Council (4) (‘the sectoral food laws’).

                     (2)

                     Commission Regulation (EU) No 234/2011 (5) lays down provisions regarding the content, drafting and presentation of applications to update the Union lists under each sectoral food law. That Regulation provides for detailed arrangements for checking the validity of applications for food additives, food enzymes and food flavourings and the type of information that should be included in the opinion of the European Food Safety Authority (‘the Authority’).

                     (3)

                     Regulation (EU) 2019/1381 of the European Parliament and the Council (6) amended Regulation (EC) No 178/2002 (7) and Regulation (EC) No 1331/2008. Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where the Authority delivers a scientific risk assessment, including in the area of food additives, food enzymes and food flavourings.

                     (4)

                     As regards the placing on the market of food additives, food enzymes and food flavourings and ingredients with flavouring properties for use in and on foods, the amendments to Regulation (EC) No 178/2002 introduced new provisions concerning, amongst other issues: general pre-submission advice by the staff of the Authority at the request of a potential applicant and the obligation to notify studies commissioned or carried out by business operators to support an application and the consequences of non-compliance with that obligation. It also introduced provisions on the public disclosure, by the Authority, of all scientific data, studies and other information supporting applications with the exception of confidential information, early on in the risk assessment process, followed up by a consultation of third parties. The amendments also set out specific procedural requirements for the submission of confidentiality requests and the assessment thereof by the Authority in relation to the information submitted by an applicant, where the Commission requests the opinion of the Authority.

                     (5)

                     Regulation (EU) 2019/1381 also amended Regulation (EC) No 1331/2008 to include provisions ensuring consistency with the adaptations of Regulation (EC) No 178/2002 and taking into account sectoral specificities with respect to confidential information.

                     (6)

                     Given the scope and application of all those amendments, Regulation (EU) No 234/2011 should be adjusted to accommodate the changes as regards the content, drafting and presentation of applications to update the Union lists under each sectoral food law, the arrangements for checking the validity of applications and the information to be included in the opinions of the Authority. In particular, Regulation (EU) No 234/2011 should make reference to the standard data formats and require that applications provide information demonstrating compliance with the notification requirement laid down in Article 32b of Regulation (EC) No 178/2002, It should also clarify that the assessment of compliance with the notification requirement forms part of the verification of the validity of an application.

                     (7)

                     Furthermore, taking into account the fact that the Authority is responsible for managing the database of studies in accordance with Article 32b of Regulation (EC) No 178/2002, it should also be made possible for the Commission to consult the Authority as part of the verification of the validity of applications to ascertain that the application fulfils the relevant requirements that are laid down in that Article.

                     (8)

                     Where public consultations are performed during the risk assessment in accordance with Article 32c(2) of Regulation (EC) No 178/2002, the opinion of the Authority should also include the results of those consultations, in line with the transparency requirements to which the Authority is subject.

                     (9)

                     This Regulation should apply from 27 March 2021 and to applications submitted as of that date, which is the date of application of Regulation (EU) 2019/1381.

                     (10)

                     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
            Amendments to Regulation (EU) No 234/2011
            Regulation (EU) No 234/2011 is amended as follows:

                        (1)

                        Article 2 is amended as follows:

                                    (a)

                                    paragraph 1 is replaced by the following:

                                       ‘1.   The application referred to in Article 1 shall consist of the following:

                                                   (a)

                                                   a letter;

                                                   (b)

                                                   a technical dossier;

                                                   (c)

                                                   a detailed summary and a public summary of the dossier.’;

                                    (b)

                                    paragraph 3 is replaced by the following:

                                       ‘3.   The technical dossier referred to in paragraph 1(b) shall contain:

                                                   (a)

                                                   the administrative data as provided for in Article 4;

                                                   (b)

                                                   the data required for risk assessment as provided for in Articles 5, 6, 8 and 10 and information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002; and

                                                   (c)

                                                   the data required for risk management as provided for in Articles 7, 9 and 11 and information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002.’;

                                    (c)

                                    paragraph 6 is replaced by the following:

                                       ‘6.   The summary of the dossier referred to in paragraph 1(c) shall include a reasoned statement that the use of the product complies with the conditions laid down in:

                                                   (a)

                                                   Article 6 of Regulation (EC) No 1332/2008; or

                                                   (b)

                                                   Articles 6, 7 and 8 of Regulation (EC) No 1333/2008; or

                                                   (c)

                                                   Article 4 of Regulation (EC) No 1334/2008.

                                             The public summary of the dossier shall not contain any information subject to a request for confidential treatment pursuant to Article 12 of Regulation (EC) No 1331/2008 and 39a of Regulation (EC) No 178/2002.’;

                        (2)

                        Article 3, paragraph 1 is replaced by the following

                           ‘1.   Prior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted through the electronic submission system provided by the Commission, in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted through the electronic submission system provided by the Commission in accordance with those standard data formats. The applicant shall take into account the practical guidance on the submission of applications made available by the Commission (Directorate-General for Health and Food Safety (*1) website).

                           (*1)  https://ec.europa.eu/food/safety_en’;"

                        (3)

                        Article 4 is amended as follows:

                                    (a)

                                    point (m) is replaced by the following:

                                                ‘(m)

                                                where the applicant submits, in accordance with Article 12 of Regulation (EC) No 1331/2008, a request to treat as confidential certain parts of the information of the dossier, including supplementary information, a list of the parts to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree;’

                                    (b)

                                    point (n) is added:

                                                ‘(n)

                                                a list of the studies submitted to support the application, including information demonstrating compliance with Article 32b of Regulation (EC) No 178/2002.’;

                        (4)

                        Article 12 is replaced by the following:

                           ‘Article 12
                           Procedures

                              1.   On receipt of an application the Commission shall, without delay, verify whether the food additive, food enzyme or flavouring falls within the scope of the appropriate sectoral food law, whether the application contains all the elements required under Chapter II and whether it fulfils the requirements set out in Article 32b of Regulation (EC) No 178/2002.

                              2.   The Commission may consult the Authority on the suitability of the data for risk assessment in accordance with the scientific opinions on data requirements for the evaluation of substance applications and on whether the application fulfils the requirements set out in Article 32b of Regulation (EC) No 178/2002. The Authority shall provide the Commission with its views within 30 working days.

                              3.   If the application is considered valid by the Commission, the evaluation period referred to in Article 5(1) of Regulation (EC) No 1331/2008 shall begin on the date of receipt of the Authority’s reply referred to in paragraph 2 of this Article.
                              However, in accordance with point (a) of the second subparagraph of Article 17(4) of Regulation (EC) No 1332/2008, in the case of establishment of the Union list of food enzymes, Article 5(1) of Regulation (EC) No 1331/2008 shall not apply.

                              4.   In case of an application to update the Union list of food additives, food enzymes or flavourings, the Commission may request additional information from the applicant on matters regarding the validity of the application and inform the applicant of the period within which that information has to be provided. In the case of applications submitted in compliance with Article 17(2) of Regulation (EC) No 1332/2008, the Commission shall determine that period together with the applicant.

                              5.   The application shall be considered not valid if:

                                          (a)

                                          it does not fall within the appropriate sectoral food law,

                                          (b)

                                          it does not contain all the elements required under Chapter II,

                                          (c)

                                          it does not comply with Article 32b of Regulation (EC) No 178/2002 or,

                                          (d)

                                          the Authority considers that the data for risk assessment are not suitable.

                                    In such a case, the Commission shall inform the applicant, the Member States and the Authority indicating the reasons why the application is considered not valid.

                              6.   By way of derogation from paragraph 5 and without prejudice to Article 32b(4) and (5) of Regulation (EC) No 178/2002, an application may be considered as valid even if it does not contain all the elements required under Chapter II, provided that the applicant has submitted appropriate justification for each missing element.’;

                        (5)

                        in Article 13(1), the following point (g) is added:

                                    ‘(g)

                                    the results of consultations performed during the risk assessment process in accordance with Article 32c(2) of Regulation (EC) No 178/2002.’;

                        (6)

                        the Annex is replaced by the Annex to this Regulation.

            Article 2
            Entry into force and application
            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 27 March 2021 and to applications submitted to the Commission from that date.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 2 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 354, 31.12.2008, p. 1.

            (2)  Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).

            (3)  Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, p. 7).

            (4)  Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).

            (5)  Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 64, 11.3.2011, p. 15).

            (6)  Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and the sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L 231, 6.9.2019, p. 1).

            (7)  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).

            ANNEX

                     ‘ANNEX

                        MODEL LETTER ACCOMPANYING AN APPLICATION FOR THE AUTHORISATION OF FOOD ADDITIVES

                     EUROPEAN COMMISSION
                     Directorate-General
                     Directorate
                     Unit
                     Date: ………………

                                 Subject:

                                    Application for the authorisation of a food additive in accordance with Regulation (EC) No 1331/2008

                                 ☐

                                 Application for the authorisation of a new food additive

                                 ☐

                                 Application for the modification of the conditions of use of an already authorised food additive

                                 ☐

                                 Application for the modification of the specifications of an already authorised food additive

                           (Please indicate clearly by ticking one of the boxes).
                     The Applicant(s) and/or his/their Representative(s) in the European Union.
                     (name, address, …)
                     ….
                     ….
                     ….
                     submit(s) the present application for the authorisation of (a) food additive(s).
                     Food additive name:
                     ….
                     ELINCS or Einecs number (if attributed):
                     CAS No (if applicable):
                     Functional class(es) of food additives (*1):
                     (list)
                     ….
                     Food categories and required levels:

                                 Food category

                                 Normal use level

                                 Maximum proposed use level

                           Yours sincerely,
                     Signature: …………………
                     Enclosures:

                                 ☐

                                 Complete dossier

                                 ☐

                                 Public summary of the dossier (non-confidential)

                                 ☐

                                 Detailed summary of the dossier

                                 ☐

                                 List of the parts of the dossier requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree

                                 ☐

                                 List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002

                                 ☐

                                 Copy of administrative data of applicant(s)

                        MODEL LETTER ACCOMPANYING AN APPLICATION FOR THE AUTHORISATION OF FOOD ENZYMES

                     EUROPEAN COMMISSION
                     Directorate-General
                     Directorate
                     Unit
                     Date: ……………………

                                 Subject:

                                    Application for the authorisation of a food enzyme in accordance with Regulation (EC) No 1331/2008

                                 ☐

                                 Application for the authorisation of a new food enzyme

                                 ☐

                                 Application for the modification of the conditions of use of an already authorised food enzyme

                                 ☐

                                 Application for the modification of the specifications of an already authorised food enzyme

                           (Please indicate clearly by ticking one of the boxes)
                     The Applicant(s) and/or his/their Representative(s) in the European Union
                     (name, address, …)
                     …
                     …
                     submit(s) the present application for the authorisation of (a) food enzyme(s).
                     Food enzyme name:
                     …
                     Enzyme Classification Number of Enzyme Commission of the IUBMB:
                     Source material:
                     …
                     …

                                 Name

                                 Specifications

                                 Foods

                                 Conditions of use

                                 Restrictions on the sale of the food enzyme to the final consumer

                                 Specific requirement in respect of labelling of food

                           Yours sincerely,
                     Signature: ……………………
                     Enclosures:

                                 ☐

                                 Complete dossier

                                 ☐

                                 Public summary of the dossier (non-confidential)

                                 ☐

                                 Detailed summary of the dossier

                                 ☐

                                 List of the parts of the dossier requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree

                                 ☐

                                 List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002

                                 ☐

                                 Copy of administrative data of applicant(s)

                        MODEL LETTER ACCOMPANYING AN APPLICATION FOR THE AUTHORISATION OF FOOD FLAVOURINGS

                     EUROPEAN COMMISSION
                     Directorate-General
                     Directorate
                     Unit
                     Date: ……………………

                                 Subject:

                                    Application for the authorisation of a food flavouring in accordance with Regulation (EC) No 1331/2008

                                 ☐

                                 Application for the authorisation of a new flavouring substance

                                 ☐

                                 Application for the authorisation of a new flavouring preparation

                                 ☐

                                 Application for the authorisation of a new flavour precursor

                                 ☐

                                 Application for the authorisation of a new thermal process flavouring

                                 ☐

                                 Application for the authorisation of a new other flavouring

                                 ☐

                                 Application for the authorisation of a new source material

                                 ☐

                                 Application for the modification of the conditions of use of an already authorised food flavouring

                                 ☐

                                 Application for the modification of the specifications of an already authorised food flavouring

                           (Please indicate clearly by ticking one of the boxes)
                     The Applicant(s) and/or his/their Representative(s) in the European Union
                     (name, address, …)
                     …
                     …
                     submit(s) the present application for the authorisation of (a) food flavouring(s).
                     Name of the flavouring or source material:
                     …
                     FL-, CAS-, JECFA-, CoE-number (if attributed):
                     Organoleptic properties of the flavouring:
                     …
                     Food categories and required levels:

                                 Food category

                                 Normal use level

                                 Maximum proposed use level

                           Yours sincerely,
                     Signature: …………………
                     Enclosures:

                                 ☐

                                 Complete dossier

                                 ☐

                                 Public summary of the dossier (non-confidential)

                                 ☐

                                 Detailed summary of the dossier

                                 ☐

                                 List of the parts of the dossier requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree

                                 ☐

                                 List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002

                                 ☐

                                 Copy of administrative data of applicant(s)

               ’

               (*1)  The functional classes of food additives in foods and of food additives in food additives and food enzymes are listed in Annex I to Regulation (EC) No 1333/2008. If the additive does not belong to one of the mentioned classes, a new functional class name and definition can be proposed.


title: Commission Implementing Regulation (EU) 2020/1824 of 2 December 2020 amending Implementing Regulation (EU) 2017/2468 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)

text:
                  3.12.2020

                  EN

                  Official Journal of the European Union

                  L 406/51

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1824
         of 2 December 2020
         amending Implementing Regulation (EU) 2017/2468 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 20 and Article 35(3) thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union.

                     (2)

                     Commission Implementing Regulation (EU) 2017/2468 (2) lays down administrative and scientific requirements concerning traditional foods from third countries.

                     (3)

                     Regulation (EU) 2019/1381 of the European Parliament and the Council (3) amended Regulation (EC) No 178/2002 of the European Parliament and of the Council (4) and Regulation (EU) 2015/2283. Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where the European Food Safety Authority (‘the Authority’) delivers a scientific risk assessment, including in the area of traditional foods from third countries.

                     (4)

                     As regards the placing on the market of traditional foods from third countries, the amendments to Regulation (EC) No 178/2002 introduced new provisions concerning, amongst other issues: general pre-submission advice by the staff of the Authority at the request of a potential applicant or notifier and the obligation to notify studies commissioned or carried out by business operators to support an application or notification and the consequences of non-compliance with that obligation. It also introduced provisions on the public disclosure by the Authority of all scientific data, studies and other information supporting applications, with the exception of confidential information, early on in the risk assessment process, followed up by a consultation of third parties. The amendments also set out specific procedural requirements for the submission of confidentiality requests and the assessment thereof by the Authority in relation to the information submitted by an applicant, where the Commission requests the opinion of the Authority.

                     (5)

                     Regulation (EU) 2019/1381 also amended Regulation (EU) 2015/2283 to provide for the public disclosure by the Authority of notifications where it submits duly reasoned safety objections as well as to include provisions ensuring consistency with the adaptations of Regulation (EC) No 178/2002 and taking into account sectoral specificities with respect to confidential information.

                     (6)

                     Given the scope and application of all those amendments, Implementing Regulation (EU) 2017/2468 should be adjusted to accommodate the changes as regards the content, drafting and presentation of notifications and applications referred to in Articles 14 and 16 of Regulation (EU) 2015/2283, the arrangements for verifying the validity of notifications and applications and the information to be included in the opinion of the Authority. In particular, Implementing Regulation (EU) 2017/2468 should make reference to the standard data formats and require that applications provide information demonstrating compliance with the notification requirement laid down in Article 32b of Regulation (EC) No 178/2002. It should also clarify that the assessment of compliance with the notification requirement forms part of the verification of the validity of an application.

                     (7)

                     Furthermore, taking into account the fact that the Authority is responsible for managing the database of studies in accordance with Article 32b of Regulation (EC) No 178/2002, it should be made possible for the Commission to consult the Authority as part of the verification of the validity of notifications and applications, in particular with a view to ascertaining that the notification or application fulfils the relevant requirements that are laid down in that Article.

                     (8)

                     Where public consultations are performed during the risk assessment in accordance with Article 32c(2) of Regulation (EC) No 178/2002, the opinion of the Authority should also include the results of those consultations in line with the transparency requirements to which the Authority is subject.

                     (9)

                     This Regulation should apply from 27 March 2021 and to notifications and applications submitted as of that date, which is the date of application of Regulation (EU) 2019/1381.

                     (10)

                     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
            Amendments to Implementing Regulation (EU) 2017/2468
            Implementing Regulation (EU) 2017/2468 is amended as follows:

                        (1)

                        Article 3 is amended as follows:

                                    (a)

                                    paragraph 1 is replaced by the following:

                                       ‘1.   A notification shall consist of the following:

                                                   (a)

                                                   a cover letter;

                                                   (b)

                                                   a technical dossier;

                                                   (c)

                                                   a summary of the dossier.
                                                   Prior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the notification shall be submitted through the electronic submission system provided by the Commission, in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the notification shall be submitted through the electronic submission system provided by the Commission in accordance with those standard data formats.’;

                                    (b)

                                    paragraph 5 is replaced by the following:

                                       ‘5.   The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283. The summary of the dossier shall not contain any information subject to a request for confidential treatment pursuant to Article 23 of Regulation (EU) 2015/2283 and Article 39a of Regulation (EC) No 178/2002.’;

                        (2)

                        Article 4 is amended as follows:

                                    (a)

                                    paragraph 1 is replaced by the following:

                                       ‘1.   An application shall consist of the following:

                                                   (a)

                                                   a cover letter;

                                                   (b)

                                                   a technical dossier;

                                                   (c)

                                                   a summary of the dossier.

                                                   (d)

                                                   duly reasoned safety objections referred to in Article 15(2) of Regulation (EU) 2015/2283;

                                                   (e)

                                                   the applicant’s response to duly reasoned safety objections.
                                                   Prior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted through the electronic submission system provided by the Commission, in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the application shall be submitted through the electronic submission system provided by the Commission in accordance with those standard data formats.’;

                                    (b)

                                    paragraph 5 is replaced by the following:

                                       ‘5.   The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283. The summary of the dossier shall not contain any information subject to a request for confidential treatment pursuant to Article 23 of Regulation (EU) 2015/2283 and Article 39a of Regulation (EC) No 178/2002.’;

                        (3)

                        Article 5 is amended as follows:

                                    (a)

                                    point (e) is replaced by the following:

                                                ‘(e)

                                                where the applicant submits, in accordance with Article 23 of Regulation (EU) 2015/2283, a request to treat as confidential certain parts of the information of the dossier, including supplementary information, a list of the parts to be treated as confidential accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree;’;

                                    (b)

                                    point (f) is added:

                                                ‘(f)

                                                a list of the studies submitted to support the notification or application, including information demonstrating compliance with Article 32b of Regulation (EC) No 178/2002.’;

                        (4)

                        Article 7 is replaced by the following:

                           ‘Article 7
                           Verification of the validity of a notification

                              1.   On receipt of a notification of a traditional food from a third country, the Commission shall, without delay, verify whether the food concerned falls within the scope of Regulation (EU) 2015/2283 and whether the notification fulfils the requirements set out in Articles 3, 5 and 6 of this Regulation and in Article 32b of Regulation (EC) No 178/2002.

                              2.   The Commission may consult the Member States and the Authority on whether the notification fulfils the requirements referred to in paragraph 1. The Member States and the Authority shall provide the Commission with their views within a period of 30 working days.

                              3.   The Commission may request additional information from the applicant as regards the validity of the notification and inform the applicant of the period within which that information has to be provided.

                              4.   By way of derogation from paragraph 1 of this Article and without prejudice to Article 14 of Regulation (EU) 2015/2283 and to Article 32b(4) and (5) of Regulation (EC) No 178/2002, a notification may be considered valid even if it does not contain all the elements required under Articles 3, 5 and 6 of this Regulation, provided that the applicant has submitted appropriate justification for each missing element.

                              5.   The Commission shall inform the applicant, the Member States and the Authority whether the notification is considered valid or not. Where the notification is not considered valid, the Commission shall indicate the reasons for that finding.’;

                        (5)

                        Article 8 is replaced by the following:

                           ‘Article 8
                           Verification of the validity of an application

                              1.   On receipt of an application for the authorisation of a traditional food from a third country the Commission shall, without delay, verify whether the application fulfils the requirements of Articles 4 to 6 of this Regulation and of Article 32b of Regulation (EC) No 178/2002.

                              2.   The Commission may consult the Authority on whether the application fulfils the requirements referred to in paragraph 1. The Authority shall provide the Commission with its views within a period of 30 working days.

                              3.   The Commission may request additional information from the applicant on matters regarding the validity of the application and inform the applicant of the period within which that information has to be provided.

                              4.   By way of derogation from paragraph 1 of this Article and without prejudice to Article 16 of Regulation (EU) 2015/2283 and to Article 32b(4) and (5) of Regulation (EC) No 178/2002, an application may be considered valid even if it does not contain all the elements required under Articles 4 to 6 of this Regulation, provided that the applicant has submitted appropriate justification for each missing element.

                              5.   The Commission shall inform the applicant, the Member States and the Authority whether the application is considered valid or not. Where the application is not considered valid, the Commission shall indicate the reasons for that finding.’;

                        (6)

                        Article 10 is amended as follows:
                        point (e) is added:

                                    ‘(e)

                                    the results of consultations performed during the risk assessment process in accordance with Article 32c(2) of Regulation (EC) No 178/2002.’;

                        (7)

                        Annexes I and II are replaced in accordance with the Annex to this Regulation;

                        (8)

                        Annex III is deleted.

            Article 2
            Entry into force and application
            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 27 March 2021 and to notifications and applications submitted to the Commission from that date.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 2 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 55).

            (3)  Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L 231, 6.9.2019, p. 1).

            (4)  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).

            ANNEX
            Annexes I and II to Regulation (EU) 2017/2468 are replaced as follows:

                        (1)

                        Annex I is replaced by the following:

                              ‘ANNEX I

                                 TEMPLATE COVER LETTER ACCOMPANYING A NOTIFICATION OF A TRADITIONAL FOOD FROM A THIRD COUNTRY IN ACCORDANCE WITH ARTICLE 14 OF REGULATION (EU) 2015/2283

                              EUROPEAN COMMISSION
                              Directorate-General
                              Directorate
                              Unit
                              Date: …
                              Subject: Notification of a traditional food from a third country in accordance with Regulation (EU) 2015/2283
                              (Please indicate clearly by ticking one of the boxes)

                                          ☐

                                          Notification for an authorisation of a new traditional food.

                                          ☐

                                          Notification for adding, removing or changing the conditions of use of an already authorised traditional food. Please provide a reference to that notification.

                                          ☐

                                          Notification for adding, removing or changing the specifications of an already authorised traditional food. Please provide a reference to that notification.

                                          ☐

                                          Notification for adding, removing or changing additional labelling requirements of an already authorised traditional food. Please provide a reference to that notification.

                                          ☐

                                          Notification for adding, removing or changing the post-market monitoring requirements of an already authorised traditional food. Please provide a reference to that notification.

                                    The Applicant(s) or their Representative(s) in the Union
                              (name(s), address(es)….)
                              …
                              …
                              …
                              submit(s) this notification in order to update the Union list on novel foods.
                              Identity of the traditional food:
                              …
                              …
                              Confidentiality. Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283

                                          ☐

                                          Yes

                                          ☐

                                          No

                                    Food categories, conditions of use and labelling requirements

                                          Food category

                                          Specific conditions of use

                                          Additional specific labelling requirement

                                          -

                                    Yours sincerely,
                              Signature …
                              Enclosures:

                                          ☐

                                          Complete technical dossier

                                          ☐

                                          Summary of the dossier (non-confidential)

                                          ☐

                                          List of the parts of the dossier requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree

                                          ☐

                                          Copy of administrative data of applicant(s)

                                          ☐

                                          List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002

                        ’

                        (2)

                        Annex II is replaced by the following:

                              ‘ANNEX II

                                 TEMPLATE COVER LETTER ACCOMPANYING AN APPLICATION FOR THE AUTHORISATION OF A TRADITIONAL FOOD FROM A THIRD COUNTRY IN ACCORDANCE WITH ARTICLE 16 OF REGULATION (EU) 2015/2283

                              EUROPEAN COMMISSION
                              Directorate-General
                              Directorate
                              Unit
                              Date: …
                              Subject: Application for the authorisation of a traditional food from a third country in accordance with Article 16 of Regulation (EU) 2015/2283
                              The Applicant(s) or their Representative(s) within the European Union
                              (name(s), address(es)….)
                              …
                              …
                              …
                              submit(s) this application in order to update the Union list on novel foods.
                              Identity of the traditional food:
                              …
                              …
                              Confidentiality. Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283

                                          ☐

                                          Yes

                                          ☐

                                          No

                                    Food categories, conditions of use and labelling requirements

                                          Food category

                                          Specific conditions of use

                                          Additional specific labelling requirement

                                    Yours sincerely,
                              Signature …
                              Enclosures:

                                          ☐

                                          Complete application

                                          ☐

                                          Summary of the application (non-confidential)

                                          ☐

                                          List of the parts of the application requested to be treated as confidential, accompanied by verifiable justification demonstrating how the disclosure of such information would potentially harm the interests of the applicant to a significant degree

                                          ☐

                                          Documented data relating to the duly reasoned safety objections

                                          ☐

                                          Copy of administrative data of applicant(s)

                                          ☐

                                          List of studies and all information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002

                        ’


title: Commission Implementing Regulation (EU) 2020/1994 of 4 December 2020 correcting Implementing Regulation (EU) 2020/1156 extending the definitive anti-dumping duty imposed by Implementing Regulation (EU) 2018/186 on imports of certain corrosion resistant steels originating in the People’s Republic of China to imports of slightly modified certain corrosion resistant steels

text:
                  7.12.2020

                  EN

                  Official Journal of the European Union

                  L 410/67

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1994
         of 4 December 2020
         correcting Implementing Regulation (EU) 2020/1156 extending the definitive anti-dumping duty imposed by Implementing Regulation (EU) 2018/186 on imports of certain corrosion resistant steels originating in the People’s Republic of China to imports of slightly modified certain corrosion resistant steels
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1), and in particular Articles 13(3), 14(1) and 14(5) thereof,
         Whereas:

                     (1)

                     By Commission Implementing Regulation (EU) 2020/1156 (2), the Commission extended the anti-dumping measures on certain corrosion resistant steels originating in the People’s Republic of China to certain slightly modified corrosion resistant steels originating in the People’s Republic of China.

                     (2)

                     In particular, the Commission concluded that the definitive anti-dumping duties imposed on the product concerned as defined in the original investigation were circumvented by imports of the slightly modified product originating in the People’s Republic of China. The investigation showed that there was a change in the pattern of trade between the People’s Republic of China and the Union which stemmed from a practice, process or work for which there was insufficient due cause or economic justification other than the imposition of the duty. The Commission also found that the remedial effects of the duties were being undermined in terms of the prices and/or quantities of the like product. Finally, the Commission found dumping for the slightly modified product in relation to the normal values previously established. Therefore, in accordance with Article 13(1) of Regulation (EU) 2016/1036 (‘the basic Regulation’), the Commission concluded that the anti-dumping measures in force on imports of certain corrosion resistant steels originating in the People’s Republic of China should be extended to imports of the slightly modified product originating in the People’s Republic of China.

                     (3)

                     Accordingly, Article 1(1) of this Regulation stated that the definitive anti-dumping duty imposed by Commission Implementing Regulation (EU) 2018/186 (3) was extended to the slightly modified product. However, such provision omitted an explicit reference to the applicable level of duties.

                     (4)

                     For the sake of clarity, and in accordance with Article 13(1), second paragraph of the basic Regulation, the extended duty is the one applicable to ‘all other companies’ in the original measures. Article 13(1) of the basic Regulation was already referred to as the basis to extend the measures in recital 64 of Implementing Regulation (EU) 2020/1156. According to Article 13(1), second paragraph of the basic Regulation, the Commission may extend the duties up to the residual anti-dumping duty imposed for the country subject to measures. Therefore, the reference to this provision as well as the findings made in the anti-circumvention investigation on the basis of facts available clearly indicate that the extended duty should be the one established in Article 1(2) of Implementing Regulation (EU) 2018/186 for ‘all other companies’, which is a definitive anti-dumping duty of 27,9 %.

                     (5)

                     Furthermore, Article 1(1) of Implementing Regulation (EU) 2020/1156 included some typographical errors, resulting in an unclear description of the product and CN codes covered by the extended anti-dumping duty, which needed to be corrected. The scope of the product under investigation (compared to the product concerned by Implementing Regulation (EU) 2018/186) was clearly defined in recitals 10 and 11 of Implementing Regulation (EU) 2020/1156.

                     (6)

                     Therefore, the Commission has decided to correct recital 64 and Article 1(1) of Implementing Regulation (EU) 2020/1156 in order to confirm the applicable level of anti-dumping duties. As set out in recital 65 and Article 1(4) of Implementing Regulation (EU) 2020/1156, the correct level of anti-dumping duty as clarified in the previous recital should also be collected on the imports of the product under investigation originating in the People’s Republic of China which entered the Union under registration imposed by the initiating Commission Implementing Regulation (EU) 2019/1948 (4). Therefore, the effects of this correction should start from the entry into force of Implementing Regulation (EU) 2020/1156 (namely, 6 August 2020) and includes the collection of the duties on the imports of the product under investigation subject to registration.

                     (7)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee, established by Article 15(1) of Regulation (EU) 2016/1036,

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   Recital 64 of Implementing Regulation (EU) 2020/1156 is replaced by the following:

                           ‘(64)

                           In accordance with Article 13(1) of the basic Regulation, the anti-dumping measures in force on imports of certain corrosion resistant steels originating in the PRC should therefore be extended to imports of the product under investigation originating in the PRC. Pursuant to Article 13(1), second paragraph of the basic Regulation, the measure to be extended should be the one established in Article 1(2) of Implementing Regulation (EU) 2018/186 for “all other companies”, which is a definitive anti-dumping duty of 27,9 % applicable to the net, free-at-Union-frontier price, before duty.’

               2.   Article 1(1) of Implementing Regulation (EU) 2020/1156 is replaced by the following:

                     2.‘1.   The definitive anti-dumping duty applicable to “all other companies” imposed by Article 1(2) of Implementing Regulation (EU) 2018/186 on imports of certain corrosion resistant steels originating in the People’s Republic of China is hereby extended to imports of flat-rolled products of iron or alloy steel or non-alloy steel; plated or coated by hot dip galvanisation with zinc and/or aluminium and/or magnesium, whether or not alloyed with silicon; chemically passivated; with or without any additional surface treatment such as oiling or sealing; containing by weight: not more than 0,5 % of carbon, not more than 1,1 % of aluminium, not more than 0,12 % of niobium, not more than 0,17 % of titanium and not more than 0,15 % of vanadium; presented in coils, cut-to-length sheets and narrow strips, currently falling under CN codes ex 7210 41 00, ex 7210 49 00, ex 7210 61 00, ex 7210 69 00, ex 7210 90 80, ex 7212 30 00, ex 7212 50 61, ex 7212 50 69, ex 7212 50 90, ex 7225 92 00, ex 7225 99 00, ex 7226 99 30, ex 7226 99 70 (TARIC codes: 7210410030, 7210490030, 7210610030, 7210690030, 7210908092, 7212300030, 7212506130, 7212506930, 7212509014, 7212509092, 7225920030, 7225990023, 7225990041, 7225990093, 7226993030, 7226997013, 7226997093), originating in the People’s Republic of China.
                     The following products are excluded:

                                 —

                                 of stainless steel, of silicon-electrical steel, and of high-speed steel,

                                 —

                                 not further worked than hot-rolled or cold-rolled (cold-reduced),

                                 —

                                 the product as defined in Article 1(1) of Implementing Regulation (EU) 2018/186.’

            Article 2
            This Regulation shall enter into force with retroactive effect as from 6 August 2020.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 4 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 176, 30.6.2016, p. 21.

            (2)  Commission Implementing Regulation (EU) 2020/1156 of 4 August 2020 extending the definitive anti-dumping duty imposed by Implementing Regulation (EU) 2018/186 on imports of certain corrosion resistant steels originating in the People’s Republic of China to imports of slightly modified certain corrosion resistant steels (OJ L 255, 5.8.2020, p. 36).

            (3)  Commission Implementing Regulation (EU) 2018/186 of 7 February 2018 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of certain corrosion resistant steels originating in the People’s Republic of China (OJ L 34, 8.2.2018, p. 16).

            (4)  Commission Implementing Regulation (EU) 2019/1948 of 25 November 2019 initiating an investigation concerning possible circumvention of anti-dumping measures imposed by Commission Implementing Regulation (EU) 2018/186 on imports of certain corrosion resistant steels originating in the People’s Republic of China, and making such imports subject to registration (OJ L 304, 26.11.2019, p. 10).