title: Commission Implementing Regulation (EU) 2021/170 of 9 February 2021 concerning the classification of certain goods in the Combined Nomenclature

text:
                  15.2.2021

                  EN

                  Official Journal of the European Union

                  L 50/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/170
         of 9 February 2021
         concerning the classification of certain goods in the Combined Nomenclature
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
         Whereas:

                     (1)

                     In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

                     (2)

                     Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

                     (3)

                     Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

                     (4)

                     It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

            Article 2
            Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of three months from the date of entry into force of 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, 9 February 2021.

                  For the Commission,

                  On behalf of the President,

               Gerassimos THOMAS

                  Director-General

                  Directorate-General for Taxation and Customs Union

            (1)  OJ L 269, 10.10.2013, p. 1.

            (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

            ANNEX

                        Description of the goods

                        Classification (CN-code)

                        Reasons

                        (1)

                        (2)

                        (3)

                        A bottle made of mechanically produced, glass, in the shape of a skull, approximately 9,5 cm high, with a nominal capacity of 180 ml. The bottle has a short neck (approximately 1,5 cm long and with a diameter of the opening of 2 cm) and a non-sealed stopper made of cork, which fits loosely in the opening of the bottle.
                        See image (*1).

                        7013 49 99

                        Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature and by the wording of CN codes 7013 , 7013 49  and 7013 49 99 .
                        Based on its objective characteristics (the specific shape of the article, the cork stopper fits loosely in the bottleneck; non-sealed cork closure), the article is not designed to be commonly used commercially for the conveyance or packing of goods within the meaning of heading 7010 . The cork closure is not suitable to ensure that the contents do not leak or spill out during transport. The design of the bottle and the loose fitting stopper make the article similar to a decanter or an oil or vinegar cruet, which are articles of a kind used as table or kitchen glassware and which are excluded from heading 7010  (see also the Harmonized System Explanatory Notes (HSEN) to heading 7010 , first paragraph and fifth paragraph exclusion (c), and the HSEN to heading 7013 , first paragraph (1)). Consequently, classification under heading 7010  as a bottle of glass, of a kind used for the conveyance or packing of goods is excluded.
                        The article is therefore to be classified under CN code 7013 49 99  as glassware of a kind used for table, kitchen or similar purposes (other than that of heading 7010  or 7018 ).

               (*1)  The image is purely for information.


title: Commission Implementing Regulation (EU) 2021/171 of 12 February 2021 amending Implementing Regulation (EU) 2019/626 as regards lists of third countries and regions thereof authorised for the entry of consignments of insects into the Union (Text with EEA relevance)

text:
                  15.2.2021

                  EN

                  Official Journal of the European Union

                  L 50/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/171
         of 12 February 2021
         amending Implementing Regulation (EU) 2019/626 as regards lists of third countries and regions thereof authorised for the entry of consignments of insects into the Union
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (1), and in particular Article 127(2) thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2017/625 lays down rules for official controls and other official activities performed by the competent authorities of the Member States in order to verify compliance with Union legislation in the area of, among others, food safety at all stages of the production, processing and distribution process. In particular, it provides that certain animals and goods are only to enter the Union from a third country or region thereof which appears on a list drawn up by the Commission for that purpose.

                     (2)

                     Commission Delegated Regulation (EU) 2019/625 (2) supplements Regulation (EU) 2017/625. In particular, Article 3 of that Delegated Regulation lays down rules regarding certain animals and goods that are only permitted to enter the Union from third countries or regions thereof included in the list for such animals and goods laid down in Commission Implementing Regulation (EU) 2019/626 (3) (as authorised for the entry into the Union of consignments of certain animals and goods intended for human consumption).

                     (3)

                     Article 20 of Implementing Regulation (EU) 2019/626 provides that consignments of insects intended for human consumption are only authorised for entry into the Union if such foods have originated in and been consigned from a third country or region thereof, listed in Annex IIIa to that Implementing Regulation. Third countries and regions thereof should only be authorised for the entry of consignments of insects into the Union and duly listed where they provide appropriate evidence and guarantees that they comply with the requirements laid down in Article 127(3) of Regulation (EU) 2017/625 and Article 4 of Delegated Regulation (EU) 2019/625.

                     (4)

                     On 15 September 2020, Vietnam provided sufficient evidence and guarantees to the Commission to be included in the list of third countries or regions thereof authorised for the entry of consignments of insects into the Union. Vietnam should therefore be included in the list set out in Annex IIIa to Implementing Regulation (EU) 2019/626, and that Annex should be amended accordingly.

                     (5)

                     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
            Annex IIIa to Implementing Regulation (EU) 2019/626 is amended in accordance with the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the third 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, 12 February 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 95, 7.4.2017, p. 1.

            (2)  Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption (OJ L 131, 17.5.2019, p. 18).

            (3)  Commission Implementing Regulation (EU) 2019/626 of 5 March 2019 concerning lists of third countries and regions thereof authorised for the entry into the European Union of certain animals and goods intended for human consumption, amending Implementing Regulation (EU) 2016/759 as regards these lists (OJ L 131, 17.5.2019, p. 31).

            ANNEX
            In Annex IIIa to Implementing Regulation (EU) 2019/626, the following entry is added after the entry for Thailand:

                           ‘VN

                           Vietnam’


title: Commission Implementing Regulation (EU) 2021/1309 of 2 August 2021 entering a name in the register of protected designations of origin and protected geographical indications [‘Värmländskt skrädmjöl’ (PGI)]

text:
                  9.8.2021

                  EN

                  Official Journal of the European Union

                  L 284/14

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1309
         of 2 August 2021
         entering a name in the register of protected designations of origin and protected geographical indications [‘Värmländskt skrädmjöl’ (PGI)]
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Sweden’s application to register the name ‘Värmländskt skrädmjöl’ was published in the Official Journal of the European Union (2).

                     (2)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Värmländskt skrädmjöl’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Värmländskt skrädmjöl’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.6. Fruit, vegetables and cereals fresh or processed, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

            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, 2 August 2021.

                  For the Commission,

                  On behalf of the President,

               Janusz WOJCIECHOWSKI

                  Member of the Commission

            (1)  OJ L 343, 14.12.2012, p. 1.

            (2)  OJ C 136, 19.4.2021, p. 8.

            (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) 2021/1310 of 6 August 2021 correcting certain language versions of Regulation (EU) No 1178/2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (Text with EEA relevance)

text:
                  9.8.2021

                  EN

                  Official Journal of the European Union

                  L 284/15

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1310
         of 6 August 2021
         correcting certain language versions of Regulation (EU) No 1178/2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 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) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (1), and in particular Articles 23(1) and 27(1) thereof,
         Whereas:

                     (1)

                     The Swedish language version of Commission Regulation (EU) No 1178/2011 (2) contains excess text in Annex I (Part-FCL), Subpart A, point FCL.025 (b), point 4 implying that an additional condition applies.

                     (2)

                     The French language version of Regulation (EU) No 1178/2011 contains an error in Annex I (Part-FCL), Subpart J, Section 2, point FCL.905.FI (c), introductory phrase that alters the meaning of the text.

                     (3)

                     The German language version of Regulation (EU) No 1178/2011 contains errors in Annex I (Part-FCL), Appendix 9, Part B, point 7 ‘Class ratings – sea’, table, Section 1, points 1.5, 1.6 and 1.7 and in Annex IV (Part-MED), Subpart B, Section 2, point MED.B.070 (c), point 3, first sentence that alter the meaning of the text.

                     (4)

                     The French, German and Swedish language versions of Regulation (EU) No 1178/2011 should therefore be corrected accordingly. The other language versions are not affected.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee provided for in Article 127 of Regulation (EU) 2018/1139,

               HAS ADOPTED THIS REGULATION:

            Article 1

               (does not concern the English language)

            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, 6 August 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 212, 22.8.2018, p. 1.

            (2)  Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 311, 25.11.2011, p. 1).


title: Commission Implementing Regulation (EU) 2021/1322 of 3 August 2021 amending Implementing Regulation (EU) 2019/2076 to make administrative changes to the Union authorisation of the biocidal product family ‘Contec IPA Product Family’ (Text with EEA relevance)

text:
                  11.8.2021

                  EN

                  Official Journal of the European Union

                  L 288/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1322
         of 3 August 2021
         amending Implementing Regulation (EU) 2019/2076 to make administrative changes to the Union authorisation of the biocidal product family ‘Contec IPA Product Family’
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) and Article 50(2) thereof,
         Whereas:

                     (1)

                     On 29 November 2019, Commission Implementing Regulation (EU) 2019/2076 (2) granted a Union authorisation with authorisation number EU-0020460-0000 to Contec Europe for the making available on the market and use of the biocidal product family ‘Contec IPA Product Family’.

                     (2)

                     On 5 February 2020, Contec Europe submitted a notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), regarding the administrative changes to the Union authorisation for the biocidal product family ‘Contec IPA Product Family’ as referred to in Section 1 of Title 1 of the Annex to that Regulation.

                     (3)

                     Contec Europe proposed the revision of the list of product trade names, including the changes in the trade names and the removal of the trade names of the individual products in the meta SPCs 1 and 2, of the summary of the product characteristics for the biocidal product family ‘Contec IPA Product Family’ as set out in Annex II to Implementing Regulation (EU) 2019/2076. The notification was recorded under the case number BC-GC057245-55 in the Register for Biocidal Products.

                     (4)

                     On 6 March 2020, the Agency submitted an opinion (4) on the proposed changes to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder fall under Article 50(3)(a) of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 of that Regulation are still met. On the same date, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.

                     (5)

                     The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family ‘Contec IPA Product Family’.

                     (6)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex II to Implementing Regulation (EU) 2019/2076 is replaced by the text in the Annex to this Regulation.

            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, 3 August 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  Commission Implementing Regulation (EU) 2019/2076 of 29 November 2019 granting a Union authorisation for the biocidal product family ‘Contec IPA Product Family’ (OJ L 316, 6.12.2019, p. 19).

            (3)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

            (4)  ECHA opinion of 2 March 2020 on the administrative change of the Union authorisation of the biocidal product family ‘Contec IPA Product Family’, https://echa.europa.eu/documents/10162/22836226/opinion_for_ua_admin_change_bc-gc057245-55_en.pdf/b848e01c-b8bb-41ac-4dff-650cbfd33ff9

            ANNEX

                     ‘ANNEX II
                     Summary of product characteristics for a biocidal product family
                     Contec IPA Product Family
                     Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     Product type 4 – Food and feed area (Disinfectants)
                     Authorisation number: EU-0020460-0000
                     R4BP asset number: EU-0020460-0000
                     PART I

                        FIRST INFORMATION LEVEL

                     1.   ADMINISTRATIVE INFORMATION
                     1.1.   Family name

                                 Name

                                 Contec IPA Product Family

                           1.2.   Product type(s)

                                 Product type(s)

                                 PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                                 PT04 – Food and feed area (Disinfectants)

                           1.3.   Authorisation holder

                                 Name and address of the authorisation holder

                                 Name

                                 Contec Europe

                                 Address

                                 Zl Du Prat, Avenue Paul Duplaix, 56000, Vannes, France

                                 Authorisation number

                                 EU-0020460-0000

                                    R4BP asset number

                                 EU-0020460-0000

                                 Date of the authorisation

                                 26 December 2019

                                 Expiry date of the authorisation

                                 30 November 2029

                           1.4.   Manufacturer(s) of the biocidal products

                                 Name of manufacturer

                                 Contec Inc.

                                 Address of manufacturer

                                 525 Locust Grove, SC 29303 Spartanburg United States

                                 Location of manufacturing sites

                                 525 Locust Grove, SC 29303 Spartanburg United States

                                 Name of manufacturer

                                 Contec Cleanroom Technology (Suzhou) Co., Ltd. China

                                 Address of manufacturer

                                 17 Longyun Road, Suzhou Industrial Park, 215024 Suzhou China

                                 Location of manufacturing sites

                                 17 Longyun Road, Suzhou Industrial Park, 215024 Suzhou China

                                 Name of manufacturer

                                 Contec Cleanroom (UK) Ltd

                                 Address of manufacturer

                                 Unit 6A, Wansbeck Business Park, Rotary Parkway, NE63 8QW Ashington, Northumberland United Kingdom

                                 Location of manufacturing sites

                                 Unit 6A, Wansbeck Business Park, Rotary Parkway, NE63 8QW Ashington, Northumberland United Kingdom

                                 Name of manufacturer

                                 Flexible Medical Packaging

                                 Address of manufacturer

                                 Unit 8 Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom

                                 Location of manufacturing sites

                                 Unit 8 Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom

                           1.5.   Manufacturer(s) of the active substance(s)

                                 Active substance

                                 Propan-2-ol

                                 Name of manufacturer

                                 Brenntag GmbH

                                 Address of manufacturer

                                 Messeallee 11, 45131 Essen, Germany

                                 Location of manufacturing sites

                                 Haven 3222, Vondelingenweg 601, 3196 KK Vondelingenplaat Netherlands

                           2.   PRODUCT FAMILY COMPOSITION AND FORMULATION
                     2.1.   Qualitative and quantitative information on the composition of the family

                                 Common name

                                 IUPAC name

                                 Function

                                 CAS number

                                 EC number

                                 Content (%)

                                 Min

                                 Max

                                 Propan-2-ol

                                 Active Substance

                                 67-63-0

                                 200-661-7

                                 62,9

                                 62,9

                           2.2.   Type(s) of formulation

                                 Formulation(s)

                                 AL (any other liquid) – RTU solution/trigger spray
                                 AL (any other liquid) – RTU wipe

                           PART II

                        SECOND INFORMATION LEVEL – META SPC(S)

                        META SPC 1

                     1.   META SPC 1 ADMINISTRATIVE INFORMATION
                     1.1.   Meta SPC 1 identifier

                                 Identifier

                                 Contec IPA Liquid Products

                           1.2.   Suffix to the authorisation number

                                 Number

                                 1-1

                           1.3.   Product type(s)

                                 Product type(s)

                                 PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                                 PT04 – Food and feed area (Disinfectants)

                           2.   META SPC 1 COMPOSITION
                     2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

                                 Common name

                                 IUPAC name

                                 Function

                                 CAS number

                                 EC number

                                 Content (%)

                                 Min

                                 Max

                                 Propan-2-ol

                                 Active Substance

                                 67-63-0

                                 200-661-7

                                 62,9

                                 62,9

                           2.2.   Type(s) of formulation of the meta SPC 1

                                 Formulation(s)

                                 AL (any other liquid) – RTU solution/trigger spray

                           3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

                                 Hazard statements

                                 Highly flammable liquid and vapour.
                                 Causes serious eye irritation.
                                 May cause drowsiness or dizziness.
                                 Repeated exposure may cause skin dryness or cracking.

                                 Precautionary statements

                                 If medical advice is needed, have product container or label at hand.
                                 Keep out of reach of children.
                                 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                                 Keep container tightly closed.
                                 Avoid breathing vapours.
                                 Wash hands thoroughly after handling.
                                 Use only outdoors or in a well-ventilated area.
                                 Wear eye protection.
                                 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                                 IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                                 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                                 Call a Poison centre if you feel unwell.
                                 If eye irritation persists: Get medical advice.
                                 In case of fire: Use alcohol resistant foam to extinguish.
                                 Store in a well-ventilated place. Keep cool.
                                 Store locked up.
                                 Dispose of contents/container in accordance with local regulations.

                           4.   AUTHORISED USE(S) OF THE META SPC 1
                     4.1.   Use description

                        Table 1

                        Use # 1 – Professional use

                                 Product type

                                 PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                                 PT04 – Food and feed area (Disinfectants)

                                 Where relevant, an exact description of the authorised use

                                 Target organism(s) (including development stage)

                                 Bacteria
                                 Mycobacteria
                                 Yeasts

                                 Field(s) of use

                                 Indoor
                                 Disinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of medical devices, healthcare industries and other critical life science applications, and in industrial food and feed preparation areas.
                                 Acceptable use temperature: room temperature (20 ± 2 °C)

                                 Application method(s)

                                 Spraying and wiping

                                 Application rate(s) and frequency

                                 50 ml product per m2 of surface.
                                 Wiping: 1 minute contact time for bacteria and myobacteria
                                 3 minutes contact time for yeast

                                 Category(ies) of users

                                 Professional

                                 Pack sizes and packaging material

                                 High-density polyethylene (HDPE) trigger spray bottle – 0,5 L – 1 L
                                 HDPE capped refill bottle – 5 L

                           4.1.1.   Use-specific instructions for use

                     See general directions for use
                     4.1.2.   Use-specific risk mitigation measures

                     See general directions for use
                     4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

                     See general directions for use
                     4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

                     See general directions for use
                     4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

                     See general directions for use
                     5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
                     5.1.   Instructions for use

                     Use at room temperature. For visibly soiled surfaces, cleaning prior to disinfection is required.
                     Wiping: Apply/Spray product to a suitable quality cleanroom wipe. Ensure the wipe is sufficiently and uniformly saturated before wiping the surface to be disinfected.
                     Ensure the surface is uniformly covered with the product then wipe to dry with a sterile cleanroom wipe.
                     Contact times: Wiping 1 minute for bacteria and mycobacteria 3 minutes for yeast.
                     Used wipes must be disposed of in a closed container.
                     5.2.   Risk mitigation measures

                     Wash hands and exposed skin before meals and after use.
                     Avoid contact with eyes

                        “For use in cleanrooms, adequate technical/engineering controls to remove airborne residues is mandatory e.g. room ventilation or LEV”

                     5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

                     Likely direct or indirect adverse effects:

                                 Headache, vertigo, hallucinations, respiratory depression, CNS depression or coma.

                                 Severe irritation of the eyes and or ocular damage.

                                 Nausea, vomiting, diarrhoea and haemorrhagic gastritis.

                                 Pulmonary aspiration hazard may induce pneumonitis, hypotension and hypoglycaemia.

                           First aid measures:

                                 Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

                                 Eye contact: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention

                                 Skin contact; wash affected area with plenty of water and soap. No scrubbing.

                                 In case of ingestion: Do NOT induce vomiting and never give anything by mouth to an impaired or unconscious individual; if the individual is unconscious place individual in left sideways (recovery) position with the head lowered and the knees bent.

                                 Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

                                 Take the individual to a healthcare centre and bring packaging or label whenever possible.

                           NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
                     Advice for medical and healthcare personnel:

                                 Monitor vital signs and provide symptomatic and supportive treatment.

                                 Evaluate endoscopic procedure in case of ingestion.

                                 Monitor glycaemia and ketones.

                                 Ipecac use is contraindicated.

                           WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTRE ☐ [INSERT LOCAL NUMBER HERE].
                     5.4.   Instructions for safe disposal of the product and its packaging

                     Dispose of contents/container in accordance with local regulations.
                     Do not re-use empty container for any other purpose.
                     5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

                     Store in a cool, dry, well-ventilated place in original container.
                     Keep away from sources of ignition.
                     Keep away from direct sunlight.
                     Keep container tightly closed.
                     Shelf-life: 2 years
                     6.   OTHER INFORMATION
                     The product contains propan-2-ol (CAS No: 67-63-0), for which an European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
                     7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
                     7.1.   Trade name(s), authorisation number and specific composition of each individual product

                                 Trade name(s)

                                 Contec IPA
                                 Contec Sterile IPA

                                 Authorisation number

                                 EU-0020460-0001 1-1

                                 Common name

                                 IUPAC name

                                 Function

                                 CAS number

                                 EC number

                                 Content (%)

                                 Propan-2-ol

                                 Active Substance

                                 67-63-0

                                 200-661-7

                                 62,9

                        META SPC 2

                     1.   META SPC 2 ADMINISTRATIVE INFORMATION
                     1.1.   Meta SPC 2 identifier

                                 Identifier

                                 Contec IPA Wipes

                           1.2.   Suffix to the authorisation number

                                 Number

                                 1-2

                           1.3.   Product type(s)

                                 Product type(s)

                                 PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                                 PT04 – Food and feed area (Disinfectants)

                           2.   META SPC 2 COMPOSITION
                     2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

                                 Common name

                                 IUPAC name

                                 Function

                                 CAS number

                                 EC number

                                 Content (%)

                                 Min

                                 Max

                                 Propan-2-ol

                                 Active Substance

                                 67-63-0

                                 200-661-7

                                 62,9

                                 62,9

                           2.2.   Type(s) of formulation of the meta SPC 2

                                 Formulation(s)

                                 AL (any other liquid) – RTU wipe

                           3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

                                 Hazard statements

                                 Highly flammable liquid and vapour.
                                 Causes serious eye irritation.
                                 May cause drowsiness or dizziness.
                                 Repeated exposure may cause skin dryness or cracking.

                                 Precautionary statements

                                 If medical advice is needed, have product container or label at hand.
                                 Keep out of reach of children.
                                 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                                 Keep container tightly closed.
                                 Avoid breathing vapours.
                                 Wash hands thoroughly after handling.
                                 Use only outdoors or in a well-ventilated area.
                                 Wear eye protection.
                                 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                                 IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                                 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                                 Call a POISON CENTRE if you feel unwell.
                                 If eye irritation persists: Get medical advice.
                                 In case of fire: Use alcohol resistant foam to extinguish.
                                 Store in a well-ventilated place. Keep cool.
                                 Store locked up.
                                 Dispose of contents/container in accordance with local regulations.

                           4.   AUTHORISED USE(S) OF THE META SPC 2
                     4.1.   Use description

                        Table 2

                        Use # 1 – Professional use

                                 Product type

                                 PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                                 PT04 – Food and feed area (Disinfectants)

                                 Where relevant, an exact description of the authorised use

                                 -

                                 Target organism(s) (including development stage)

                                 Bacteria
                                 Mycobacteria
                                 Yeasts

                                 Field(s) of use

                                 Indoor
                                 Disinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of medical devices, healthcare industries and other critical life science applications, and in industrial food and feed preparation areas.
                                 Acceptable use temperature: room temperature (20 ± 2 °C)

                                 Application method(s)

                                 Wiping

                                 Application rate(s) and frequency

                                 1 minute contact time for bacteria and mycobacteria
                                 3 minutes contact time for yeast

                                 Category(ies) of users

                                 Professional

                                 Pack sizes and packaging material

                                 Impregnated 100 % polypropylene wipes in:

                                             —

                                             HDPE canister with HDPE cap – 150 wipes (1,7 L or 2,15 L)

                                             —

                                             Polyethylene terephthalate (PET)/polyethylene (PE) packet sealed with PET/PE flow wrap – 30, 40 or 50 wipes

                                       Impregnated 100 % polyester wipes in:

                                             —

                                             HDPE canister with HDPE cap – 100 wipes (2,25 L)

                                             —

                                             PET/PE packet sealed with PET/PE flow wrap – 20 wipes

                                       Impregnated 100 % knitted polyester wipes in:

                                             —

                                             PET/PE packet sealed with PET/PE flow wrap – 8, 10, 20, 30 or 50 wipes

                                       Impregnated 55 % cellulose/45 % polyester wipes in:

                                             —

                                             HDPE canister with HDPE cap – 100 wipes (2,25 L)

                                             —

                                             PET/PE packet sealed with PET/PE flow wrap – 24, 30, 50 or 75 wipes

                                       Impregnated 50 % rayon/50 % polyester wipes in:

                                             —

                                             HDPE canister with HDPE cap – 700 wipes (11,4 L)

                           4.1.1.   Use-specific instructions for use

                     See general directions for use
                     4.1.2.   Use-specific risk mitigation measures

                     See general directions for use
                     4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

                     See general directions for use
                     4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

                     See general directions for use
                     4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

                     See general directions for use
                     5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
                     5.1.   Instructions for use

                     For soiled surfaces, cleaning prior to disinfection is required.
                     Ensure the surface is uniformly covered with the product, allow to act for a contact time of 1 minute for bactericidal and mycobactericidal action and 3 minutes for yeasticidal action
                     5.2.   Risk mitigation measures

                     Wash hands and exposed skin before meals and after use.
                     Avoid contact with eyes

                        “For use in cleanrooms, adequate technical/engineering controls to remove airborne residues is mandatory e.g. room ventilation or LEV”

                     5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

                     Likely direct or indirect adverse effects:

                                 Headache, vertigo, hallucinations, respiratory depression, CNS depression or coma.

                                 Severe irritation of the eyes and or ocular damage.

                                 Nausea, vomiting, diarrhoea and haemorrhagic gastritis.

                                 Pulmonary aspiration hazard may induce pneumonitis, hypotension and hypoglycaemia.

                           First aid measures:

                                 Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

                                 Eye contact: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention

                                 Skin contact; wash affected area with plenty of water and soap, No scrubbing.

                                 In case of ingestion; Do NOT induce vomiting and never give anything by mouth to an impaired or unconscious individual; if the individual is unconscious place individual in left sideways (recovery) position with the head lowered and the knees bent.

                                 Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

                                 Take the individual to a healthcare centre and bring packaging or label whenever possible.

                           NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
                     Advice for medical and healthcare personnel:

                                 Monitor vital signs and provide symptomatic and supportive treatment.

                                 Evaluate endoscopic procedure in case of ingestion.

                                 Monitor glycaemia and ketones.

                                 Ipecac use is contraindicated.

                           WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTRE ☐ [INSERT LOCAL NUMBER HERE].
                     5.4.   Instructions for safe disposal of the product and its packaging

                     Dispose of contents/container in accordance with local regulations.
                     Do not re-use empty container for any other purpose.
                     Used wipes must be disposed in a closed container
                     Dispose of used wipes by dry waste to landfill
                     5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

                     Store in a cool, dry, well-ventilated place in original container.
                     Keep away from sources of ignition.
                     Keep away from direct sunlight.
                     Keep container tightly closed.
                     Shelf-life: 2 years
                     6.   OTHER INFORMATION
                     Polypropylene, polyester, kitted polyester, 55 % cellulose/45 % polyester or 50 % rayon/50 % polyester wipes, 34-240 gsm, containing 5 – 38 ml product (2,75 – 20,9 g propan-2-ol)
                     The product contains propan-2-ol (CAS No: 67-63-0), for which an European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
                     7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
                     7.1.   Trade name(s), authorisation number and specific composition of each individual product

                                 Trade name(s)

                                 PROSAT EasyReach
                                 PROSAT Sterile EasyReach
                                 PROSAT Wipes
                                 PROSAT Sterile Wipes
                                 SATWipes Wipes
                                 SATWipes Sterile Wipes
                                 Cleanroom wipes, presaturated Spec-Wipe

                                 Authorisation number

                                 EU-0020460-0002 1-2

                                 Common name

                                 IUPAC name

                                 Function

                                 CAS number

                                 EC number

                                 Content (%)

                                 Propan-2-ol

                                 Active Substance

                                 67-63-0

                                 200-661-7

                                 62,9

               ’

               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

               (2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.


title: Commission Implementing Regulation (EU) 2021/1324 of 10 August 2021 amending Regulation (EC) No 1597/2002 as regards the format for the submission of national lists of the basic material of forest reproductive material

text:
                  11.8.2021

                  EN

                  Official Journal of the European Union

                  L 288/19

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1324
         of 10 August 2021
         amending Regulation (EC) No 1597/2002 as regards the format for the submission of national lists of the basic material of forest reproductive material
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 1999/105/EC of 22 December 1999 on the marketing of forest reproductive material (1), and in particular Article 10(3) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 1597/2002 (2) lays down a standardised format for Member States to submit to the Commission national lists of basic material of forest reproductive material.

                     (2)

                     The Commission has recently developed an information system for the electronic submission of those national lists, called Forest Reproductive Material Information System (FOREMATIS). FOREMATIS allows Member States to publish their national lists on the website of the Commission.

                     (3)

                     Due to that technical development, the format of national lists provided for by Regulation (EC) No 1597/2002 should be replaced by that of FOREMATIS.

                     (4)

                     Regulation (EC) No 1597/2002 should therefore be amended accordingly.

                     (5)

                     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
            Regulation (EC) No 1597/2002 is amended as follows:

                        (1)

                        Article 1 is replaced by the following:

                           ‘Article 1
                           The national list referred to in Article 10(2) of Directive 1999/105/EC shall be submitted by each Member State through and in accordance with the format of the Forest Reproductive Material Information System of the Commission (*1).

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

                        (2)

                        the Annex is deleted.

            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, 10 August 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 11, 15.1.2000, p. 17.

            (2)  Commission Regulation (EC) No 1597/2002 of 6 September 2002 laying down detailed rules for the application of Council Directive 1999/105/EC as regards the format of national lists of the basic material of forest reproductive material (OJ L 240, 7.9.2002, p. 34).


title: Commission Implementing Regulation (EU) 2021/1326 of 10 August 2021 authorising the placing on the market of Schizochytrium sp. (FCC-3204) oil 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:
                  11.8.2021

                  EN

                  Official Journal of the European Union

                  L 288/24

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1326
         of 10 August 2021
         authorising the placing on the market of Schizochytrium sp. (FCC-3204) oil 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)

                     On 23 January 2019, the company Fermentalg (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 for an extension of use of the novel food Schizochytrium sp. oil. The applicant requested to extend the use of Schizochytrium sp. oil to infant formula and follow-on formula intended for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (3). The strain of Schizochytrium sp. used by the applicant and concerned by that application is specified as strain FCC-3204.

                     (4)

                     On 15 April 2019, the applicant submitted another application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 requesting to change the conditions of use of the novel food Schizochytrium sp. oil. The applicant requested to increase the maximum level of Schizochytrium sp. oil in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4) for the adult population, excluding pregnant and lactating women. The strain of Schizochytrium sp. used by the applicant and concerned by that application is the same strain FCC-3204 as above.

                     (5)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 13 May 2019, requesting it to provide a scientific opinion by carrying out an assessment for an extension of the use of Schizochytrium sp. oil as a novel food in infant formula and follow-on formula.

                     (6)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the Authority on 10 July 2019, requesting it to provide a scientific opinion by carrying out an assessment for the change of the conditions of use of Schizochytrium sp. oil as a novel food in food supplements.

                     (7)

                     On 24 November 2020, the Authority adopted its scientific opinions on the ‘Safety of oil from Schizochytrium
                        limacinum (strain FCC-3204) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283’ (5) and ‘Safety of oil from Schizochytrium limacinum (strain FCC-3204) for use in food supplements as a novel food pursuant to Regulation (EU) 2015/2283’ (6). These opinions are in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (8)

                     In these opinions, the Authority confirmed that the strain FCC-3204 belongs to the species Schizochytrium limacinum, which was attributed the qualified presumption of safety (‘QPS’) status and included in 2020 in the list of QPS-recommended biological agents intentionally added to food or feed (7).

                     (9)

                     The Authority concluded that Schizochytrium sp. oil produced from the strain FCC-3204, belonging to the species Schizochytrium limacinum, is safe under the proposed conditions of use in infant formula and in follow-on formula and at the maximum level of 1 g/day in food supplements.

                     (10)

                     With regard to the application concerning the food supplements, the Authority considered that the data provided by the applicant were not sufficient to conclude on the safety of the novel food at the proposed uses (3 g DHA/day in food supplements for adults, excluding pregnant and lactating women). However, the Authority in its 2012 scientific opinion on the ‘Tolerable Upper Intake Level of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA)’ (8) concluded that supplemental intakes of DHA alone up to about 1 g/day do not raise safety concerns for the general population. In line with the conclusions made by the Authority, and taking into account the Member States views, the Commission is of the view that this authorisation should concern general population above 3 years of age.

                     (11)

                     A labelling requirement should be provided in order to properly inform the consumers that the food supplements containing Schizochytrium sp. (FCC-3204) oil should not be consumed by infants and children under 3 years of age.

                     (12)

                     Data submitted by the applicant did not allow for a conclusion on the safety of oil produced from other strains of the Schizochytrium microalgae genus. Therefore, the opinions of the Authority do not give sufficient grounds to establish that oil produced from other strains of Schizochytrium microalgae genus when used in infant formula and follow-on formula and with increased levels in food supplements fulfil the requirements of Article 12(1) of Regulation (EU) 2015/2283.

                     (13)

                     Following the Authority’s opinions and taking into account that authorised Schizochytrium sp. oil for which an extension of use was requested is neither species-specific nor strain-specific, it is therefore necessary to authorise the placing on the market of oil from strain FCC-3204 of Schizochytrium sp. under the assessed conditions of use, and not an extension of use of oil from all strains of the Schizochytrium genus as requested by the applicant.

                     (14)

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

                     (15)

                     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.   Schizochytrium sp. (FCC-3204) oil 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 to this Regulation.

            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, 10 August 2021.

                  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)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

            (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 2021;19(1):6344.

            (6)  EFSA Journal 2021;19(1):6345.

            (7)  EFSA BIOHAZ Panel, 2020. Statement on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 11: suitability of taxonomic units notified to EFSA until September 2019. EFSA Journal 2020;18(2):5965, 57 pp.

            (8)  EFSA Journal 2012;10(7):2815.

            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

                                    Data protection

                                       Schizochytrium sp. (FCC-3204) oil

                                       Specified food category

                                       Maximum levels of DHA

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “Oil from the microalgae Schizochytrium sp.”.
                                    The labelling of food supplements containing Schizochytrium sp. (FCC-3204) oil shall bear a statement that they should not be consumed by infants and children under 3 years of age.’

                                    Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

                                    In accordance with Regulation (EU) No 609/2013

                                    Food supplements as defined in Directive 2002/46/EC for the general population above 3 years of age

                                    1 g/day

                        (2)

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

                                    ‘Authorised Novel Food

                                    Specifications

                                       Schizochytrium sp. (FCC-3204) oil

                                       Description/Definition:

                                                The novel food is an oil produced from the strain FCC-3204 of the microalgae Schizochytrium sp.

                                       Composition:

                                                Acid value: ≤ 0,5 mg KOH/g

                                                Peroxide value (PV): ≤ 5,0 meq/kg oil

                                                Moisture and volatiles: ≤ 0,05 %

                                                Unsaponifiables: ≤ 4,5 %

                                                Trans-fatty acids: ≤ 1,0 %

                                                Docosahexaenoic acid (DHA): ≥ 32,0 %

                                                p-anisidine value: ≤ 10’