title: Commission Implementing Regulation (EU) 2021/863 of 28 May 2021 initiating an investigation concerning possible circumvention of the countervailing measures imposed by Implementing Regulation (EU) 2020/776 on imports of certain woven and/or stitched glass fibre fabrics originating in People’s Republic of China and Egypt by imports of certain woven and/or stitched glass fibre fabrics consigned from Morocco,whether declared as originating in Morocco or not, and making such imports subject to registration

text:
                  31.5.2021

                  EN

                  Official Journal of the European Union

                  L 190/76

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/863
         of 28 May 2021
         initiating an investigation concerning possible circumvention of the countervailing measures imposed by Implementing Regulation (EU) 2020/776 on imports of certain woven and/or stitched glass fibre fabrics originating in People’s Republic of China and Egypt by imports of certain woven and/or stitched glass fibre fabrics consigned from Morocco,whether declared as originating in Morocco or not, and making such imports subject to registration
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (1) (‘the basic Regulation’), and in particular Articles 23(4) and 24(5) thereof,
         After having informed the Member States,
         Whereas:
         A.   REQUEST

                     (1)

                     The European Commission (‘the Commission’) has received a request pursuant to Articles 23(4) and 24(5) of the basic Regulation, to investigate the possible circumvention of the countervailing measures imposed on imports of certain woven and/or stitched glass fibre fabrics originating in People’s Republic of China and Egypt and to make imports of certain woven and/or stitched glass fibre fabrics consigned from Morocco, whether declared as originating in Morocco or not, subject to registration.

                     (2)

                     The request was lodged on 19 May 2021 by TECH-FAB Europe e.V.

               B.   PRODUCT

                     (3)

                     The product concerned by the possible circumvention is fabrics of woven, and/or stitched continuous filament glass fibre rovings and/or yarns with or without other elements, excluding products which are impregnated or pre-impregnated (pre-preg), and excluding open mesh fabrics with cells with a size of more than 1,8 mm in both length and width and weighing more than 35 g/m2 classified on the date of entry into force of Commission Implementing Regulation (EU) 2020/776 (2) under CN codes ex 7019 39 00, ex 7019 40 00, ex 7019 59 00 and ex 7019 90 00 (TARIC codes 7019390080, 7019400080, 7019590080 and 7019900080) and originating in People’s Republic of China and Egypt (‘the product concerned’). This is the product to which the measures that are currently in force apply.

                     (4)

                     The product under investigation is the same as that defined in the previous recital, currently falling under CN codes ex 7019 39 00, ex 7019 40 00, ex 7019 59 00 and ex 7019 90 00, but consigned from Morocco, whether declared as originating in Morocco or not (TARIC codes 7019390081, 7019400081, 7019590081 and 7019900081) (‘the product under investigation’).

               C.   EXISTING MEASURES

                     (5)

                     The measures currently in force and possibly being circumvented are countervailing measures imposed by Implementing Regulation (EU) 2020/776 imposing definitive countervailing duties on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt and amending Implementing Regulation (EU) 2020/492 (3) imposing definitive anti-dumping duties on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt (‘the existing measures’).

               D.   GROUNDS

                     (6)

                     The request contains sufficient evidence that the existing countervailing measures on imports of the product concerned are being circumvented by imports of the product under investigation. In particular, the evidence available to the Commission shows the following.

                     (7)

                     A change in the pattern of trade involving exports from the People’s Republic of China and Egypt and Morocco to the Union has taken place following the imposition of measures on the product concerned.

                     (8)

                     This change appears to stem from a practice for which there is insufficient due cause or economic justification other than the imposition of the duty, namely the consignment of the product concerned via Morocco to the Union with or without having undergone some assembly or completion operation in Morocco.

                     (9)

                     Furthermore, the evidence tends to show that the practice described above undermines the remedial effects of the existing countervailing measures on the product concerned both in terms of quantity and prices. Significant volumes of imports of the product under investigation appear to have entered the EU market. In addition, there is sufficient evidence that imports of the product under investigation are made at injurious prices.

                     (10)

                     Finally, the evidence tends to show that the product under investigation and/or parts thereof still benefit from the subsidy. Indeed, the product under investigation and the parts thereof are produced by and exported to Morroco by companies in China and Egypt that were found to receive countervailable subsidies for the production and sale of the product under investigation under the existing measures.

                     (11)

                     If the investigation would identify other circumvention practices covered by Article 23 of the basic Regulation than the ones mentioned above, then the investigation may also cover these practices.

               E.   PROCEDURE

                     (12)

                     In light of the above, the Commission has concluded that sufficient evidence exists to justify the initiation of an investigation pursuant to Article 23(4) of the basic Regulation and to make imports of the product under investigation subject to registration, in accordance with Article 24(5) of the basic Regulation.

                     (13)

                     In order to obtain the information necessary for this investigation, all interested parties should contact the Commission forthwith, but not later than the time-limit set in Article 3(2) of this Regulation. The time-limit set in Article 3(2) of this Regulation applies to all interested parties. If appropriate, information may also be sought from the Union industry.

                     (14)

                     The authorities of Morocco, the People’s Republic of China and Egypt will be notified of the initiation of the investigation.

               (a)   Instructions for making written submissions and sending completed questionnaires and correspondence

                     (15)

                     Information submitted to the Commission for the purpose of trade defence investigations shall be free from copyrights. Interested parties, before submitting to the Commission information and/or data which is subject to third party copyrights, must request specific permission to the copyright holder explicitly allowing a) the Commission to use the information and data for the purpose of this trade defence proceeding and b) to provide the information and/or data to interested parties to this investigation in a form that allows them to exercise their right of defence.

                     (16)

                     All written submissions, including the information requested in this Regulation, completed questionnaires and correspondence provided by interested parties for which confidential treatment is requested shall be labelled ‘Sensitive’ (4). Parties submitting information in the course of this investigation are invited to reason their request for confidential treatment.

                     (17)

                     Parties providing ‘Sensitive’ information are required to furnish non-confidential summaries of it pursuant to Article 29(2) of the basic Regulation, which will be labelled ‘For inspection by interested parties’. These summaries should be sufficiently detailed to permit a reasonable understanding of the substance of the information submitted in confidence.

                     (18)

                     If a party providing confidential information fails to show good cause for a confidential treatment request or does not furnish a non-confidential summary of it in the requested format and quality, the Commission may disregard such information unless it can be satisfactorily demonstrated from appropriate sources that the information is correct.

                     (19)

                     Interested parties are invited to make all submissions and requests via TRON.tdi (https://webgate.ec.europa.eu/tron/TDI) including scanned powers of attorney and certification sheets.

                     (20)

                     In order to have access to TRON.tdi, interested parties need an EU Login account. Full instructions on how to register and use TRON.tdi are available on https://webgate.ec.europa.eu/tron/resources/documents/gettingStarted.pdf.

                     (21)

                     By using TRON.tdi or email, interested parties express their agreement with the rules applicable to electronic submissions contained in the document ‘CORRESPONDENCE WITH THE EUROPEAN COMMISSION IN TRADE DEFENCE CASES’ published on the website of the Directorate-General for Trade: http://trade.ec.europa.eu/doclib/docs/2011/june/tradoc_148003.pdf.

                     (22)

                     The interested parties must indicate their name, address, telephone and a valid email address and they should ensure that the provided email address is a functioning official business email which is checked on a daily basis. Once contact details are provided, the Commission will communicate with interested parties by email only, unless they explicitly request to receive all documents from the Commission by another means of communication or unless the nature of the document to be sent requires the use of a registered mail. For further rules and information concerning correspondence with the Commission including principles that apply to submissions by email, interested parties should consult the communication instructions with interested parties referred to above.
                     Commission address for correspondence:

                                 European Commission

                                 Directorate-General for Trade

                                 Directorate G

                                 Office: CHAR 04/039

                                 1049 Brussels

                                 BELGIUM

                           TRON.tdi: https://webgate.ec.europa.eu/tron/tdi
                     Email: TRADE-GFF-AC@ec.europa.eu

               (b)   Collection of information and holding of hearings

                     (23)

                     All interested parties including the Union industry, importers and any relevant associations are invited to make their views known in writing and to provide supporting evidence provided that such submissions are made within the deadline provided for in Article 3(2). Furthermore, the Commission may hear interested parties, provided that they make a request in writing and show that there are particular reasons why they should be heard.

               (c)   Requests for exemptions

                     (24)

                     In accordance with Article 23(5) of the basic Regulation, imports of the product under investigation may be exempted from measures if the importation does not constitute circumvention.

                     (25)

                     Since the possible circumvention takes place outside the Union, exemptions may be granted, in accordance with Article 23(4) of the basic Regulation, to producers of the product under investigation in Morocco who can show that they are not engaged in circumvention practices as defined in Articles 23(3) of the basic Regulation. Producers, if any, wishing to obtain an exemption should make themselves known within the time-limit indicated in Article 3(1) of this Regulation. Copies of the questionnaire for exporting producers in People’s Republic of China and Egypt, the questionnaire for exporting producers in Morocco requesting an exemption, and the questionnaire for importers are available in the file for inspection by interested parties and on DG Trade’s website: https://trade.ec.europa.eu/tdi/case_details.cfm?id=2528. The questionnaires have to be submitted within the time-limit indicated in Article 3(2) of this Regulation.

               F.   REGISTRATION

                     (26)

                     Pursuant to Article 24(5) of the basic Regulation, imports of the product under investigation shall be made subject to registration in order to ensure that, should the investigation result in findings of circumvention, countervailing duties of an appropriate amount, not exceeding the residual duty imposed by Implementing Regulation (EU) 2020/776, can be levied from the date on which registration of such imports was imposed.

               G.   TIME-LIMITS

                     (27)

                     In the interest of sound administration, time-limits should be stated within which:

                                 —

                                 interested parties may make themselves known to the Commission, submit questionnaires, present their views in writing or any other information to be taken into account during the investigation,

                                 —

                                 producers in Morocco may request exemptions from measures,

                                 —

                                 interested parties may make a written request to be heard by the Commission.

                     (28)

                     Attention is drawn to the fact that the exercise of procedural rights set out in the basic Regulation therefore depends on parties making themselves known within the time-limits laid down in Article 3 of this Regulation.

               H.   NON-COOPERATION

                     (29)

                     If any interested party refuses access to or does not provide the necessary information within the time-limits, or significantly impedes the investigation, findings, affirmative or negative, may be made on the basis of facts available in accordance with Article 28 of the basic Regulation.

                     (30)

                     Where it is found that any interested party has supplied false or misleading information, the information shall be disregarded and use may be made of facts available in accordance with Article 28 of the basic Regulation.

                     (31)

                     If an interested party does not cooperate or cooperates only partially and findings are therefore based on the facts available in accordance with Article 28 of the basic Regulation, the result may be less favourable to that party than if it had cooperated.

               I.   SCHEDULE OF THE INVESTIGATION

                     (32)

                     The investigation will be concluded, pursuant to Article 23(4) of the basic Regulation, within nine months of the date of entry into force of this Regulation.

               J.   PROCESSING OF PERSONAL DATA

                     (33)

                     It is noted that any personal data collected in this investigation will be treated in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (5).

                     (34)

                     A data protection notice that informs all individuals of the processing of personal data in the framework of Commission’s trade defence activities is available on DG Trade’s website: http://ec.europa.eu/trade/policy/accessing-markets/trade-defence/.

               K.   HEARING OFFICER

                     (35)

                     Interested parties may request the intervention of the Hearing Officer for trade proceedings. The Hearing Officer reviews requests for access to the file, disputes regarding the confidentiality of documents, requests for extension of time limits and any other request concerning the rights of defence of interested parties and third parties as may arise during the proceeding.

                     (36)

                     The Hearing Officer may organise hearings and mediate between the interested party/-ies and Commission services to ensure that the interested parties’ rights of defence are being fully exercised. A request for a hearing with the Hearing Officer should be made in writing and should specify the reasons for the request. The Hearing Officer will examine the reasons for the requests. These hearings should only take place if the issues have not been settled with the Commission services in the due course.

                     (37)

                     Any request must be submitted in good time and expeditiously so as not to jeopardise the orderly conduct of proceedings. To that effect, interested parties should request the intervention of the Hearing Officer at the earliest possible time following the occurrence of the event justifying such intervention. Where hearing requests are submitted outside the relevant timeframes, the Hearing Officer will also examine the reasons for such late requests, the nature of the issues raised and the impact of those issues on the rights of defence, having due regard to the interests of good administration and the timely completion of the investigation.

                     (38)

                     For further information and contact details interested parties may consult the Hearing Officer’s web pages on DG TRADE’s website: http://ec.europa.eu/trade/trade-policy-and-you/contacts/hearing-officer/

               HAS ADOPTED THIS REGULATION:

            Article 1
            An investigation is initiated pursuant to Article 23(4) of Regulation (EU) 2016/1037, in order to determine if imports of fabrics of woven, and/or stitched continuous filament glass fibre rovings and/or yarns with or without other elements, excluding products which are impregnated or pre-impregnated (pre-preg), and excluding open mesh fabrics with cells with a size of more than 1,8 mm in both length and width and weighing more than 35 g/m2, currently classified under CN codes ex 7019 39 00, ex 7019 40 00, ex 7019 59 00 and ex 7019 90 00 consigned from Morocco, whether declared as originating in Morocco or not, (TARIC codes 7019390081, 7019400081, 7019590081 and 7019900081) are circumventing the measures imposed by Implementing Regulation (EU) 2020/776.

            Article 2

               1.   The customs authorities of the Member States shall, pursuant to Articles 23(4) and 24(5) of Regulation (EU) 2016/1037, take the appropriate steps to register the imports identified in Article 1 of this Regulation.

               2.   Registration shall expire nine months following the date of entry into force of this Regulation.

            Article 3

               1.   Interested parties must make themselves known by contacting the Commission within 15 days from the date of entry into force of this Regulation.

               2.   Interested parties, if their representations are to be taken into account during the investigation, must present their views in writing and submit questionnaire replies, requests for exemptions, or any other information within 37 days from the date of the publication of this Regulation in the Official Journal of the European Union, unless otherwise specified.

               3.   Interested parties may also apply to be heard by the Commission within the same 37-day time limit. For hearings pertaining to the initiation stage of the investigation the request must be submitted within 15 days of the date of entry into force of this Regulation. Any request to be heard must be made in writing and must specify the reasons for the request.

            Article 4
            This Regulation shall enter into force on the 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, 28 May 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 176, 30.6.2016, p. 55.

            (2)  Commission Implementing Regulation (EU) 2020/776 of 12 June 2020 imposing definitive countervailing duties on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt and amending Commission Implementing Regulation (EU) 2020/492 imposing definitive anti-dumping duties on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt (OJ L 189, 15.6.2020, p. 1).

            (3)  Commission Implementing Regulation (EU) 2020/492 of 1 April 2020 imposing definitive anti-dumping duties on imports of certain woven and/or stitched glass fibre fabrics originating in the People’s Republic of China and Egypt (OJ L 108, 6.4.2020, p. 1).

            (4)  A ‘Sensitive’ document is a document which is considered confidential pursuant to Article 29 of the basic Regulation and Article 12 of the WTO Agreement on Subsidies and Countervailing Measures (SCM Agreement). It is also a document protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council (OJ L 145, 31.5.2001, p. 43).

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


title: Commission Implementing Regulation (EU) 2021/865 of 28 May 2021 entering a name in the register of protected designations of origin and protected geographical indications (‘Rooibos’/‘Red Bush’ (PDO))

text:
                  31.5.2021

                  EN

                  Official Journal of the European Union

                  L 190/88

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/865
         of 28 May 2021
         entering a name in the register of protected designations of origin and protected geographical indications (‘Rooibos’/‘Red Bush’ (PDO))
         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(3)(a) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, the application from South Africa to register the name ‘Rooibos’/‘Red Bush’ as protected designation of origin (PDO) was published in the Official Journal of the European Union (2).

                     (2)

                     On 7 September 2020 the Commission received the notice of opposition and the related reasoned statement of opposition from the United Kingdom. The Commission forwarded the notice of opposition and the reasoned statement of opposition sent by United Kingdom to South Africa on 16 September 2020.

                     (3)

                     The Commission examined the opposition sent by the United Kingdom and found it admissible. The opposition claims that registration of the name ‘Rooibos’/‘Red Bush’ does not comply with the conditions laid down in Article 5 and 7(1) of Regulation (EU) No 1151/2012 as the proposed description of the product and of raw materials are inconsistent. The opposition claims further that the proposed rules concerning labelling of ‘Rooibos’/‘Red Bush’ are not specific enough and in contradiction to conditions set out in Regulation (EU) No 1169/2011 of the European Parliament and of the Council (3).

                     (4)

                     By letter of 22 September 2020 the Commission invited the interested parties to engage in appropriate consultations to seek agreement among themselves in accordance with their internal procedures.

                     (5)

                     South Africa and the United Kingdom reached an agreement, which was communicated by South Africa to the Commission on 11 November 2020, within the prescribed deadline.

                     (6)

                     South Africa and the United Kingdom concluded that protection of the designation ‘Rooibos’/‘Red Bush’ (PDO) should be granted with some modifications to the single document, including consistent reference throughout the document to ten flavours, the references to aspelathin and nothofagin being expanded to make reference to the fact that it will be controlled according to the South African GI protection at origin as well as revised rules concerning labelling of the product.

                     (7)

                     As it complies with the provisions of Regulation (EU) No 1151/2012 and EU legislation, the content of the agreement concluded between South Africa and the United Kingdom should be taken into account.

                     (8)

                     On 7 September 2020 the Commission received the notice of opposition and the related reasoned statement of opposition from the Swiss Association of Tea, Spices and related Products (IGTG).

                     (9)

                     The Commission examined the opposition sent by the IGTG and found it inadmissible as none of the grounds provided in the Article 10(1) of Regulation (EU) No 1151/2012 has been substantiated in the reasoned statement submitted by the IGTG. By letter of 4 December 2020 the Commission informed the IGTG by that it will not send to the IGTG an invitation to start appropriate consultations with South Africa. By letter of 8 December 2020 addressed to the Commission the IGTG withdrew its opposition against the registration of the designation ‘Rooibos’/‘Red Bush’ (PDO).

                     (10)

                     Accordingly, the designation of origin ‘Rooibos’/‘Red Bush’ (PDO) should be entered into the register. The consolidated version of the single document should be published for information,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Rooibos’/‘Red Bush’ (PDO) is registered.
            The name in the first paragraph identifies a product from Class 1.8. Other products listed in Annex I to the Treaty (spices etc.). The consolidated single document is set out 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, 28 May 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  OJ C 190, 8.6.2020, p. 46.

            (3)  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).

            ANNEX

               ‘ROOIBOS’/’RED BUSH’

               EU No: PDO-ZA-2427 – 21.8.2018

               PDO (X) PGI ()

            1.   Name(s) [of PDO or PGI]

            ‘Rooibos’/’Red Bush’
            2.   Member State or Third Country

            South Africa
            3.   Description of the agricultural product or foodstuff

            3.1.   Type of product [listed in Annex XI]

            Class 1.8. Other products listed in Annex I to the Treaty (spices etc.)
            3.2.   Description of product to which the name in (1) applies

            The name of ‘Rooibos’/’Red Bush’ can only be used to refer to the dried leaves and stems of 100 % pure ‘Rooibos’/’Red Bush’ – derived from Aspalathus linearis and that has been cultivated or wild-harvested in the geographic area as described in this application.
            ‘Rooibos’/’Red Bush’ is presented in two forms: a) oxidised and b) green (unoxidised) dried leaves and stems of Aspalathus linearis.

                        (a)

                        In the case of oxidised dried leaves and stems of Aspalathus linearis, ‘Rooibos’/’Red Bush’ has a distinctive colour that ranges from light brown, yellow to a shiny brick-red colour. It may also have some lighter coloured sticks (dried pieces of stem) mixed with the rest of the product. The moisture level of ‘Rooibos’/’Red Bush’ is below 10 %.

                        (b)

                        Green (unoxdised) ‘Rooibos’/’Red Bush’ is the unoxidised dried leaves and stems of the Aspalathus linearis plant. Any sign of browning or oxidation is absent from green (unoxidised) ‘Rooibos/Red Bush’. Green (unoxidised) ‘Rooibos’/’Red Bush’ leaves have a dominant light green colour and it includes reddish brown thin stem and white woody pieces. The moisture level of green (unoxidised) ‘Rooibos’/’Red Bush’ is below 5 %.

                  The flavour and taste of ‘Rooibos’/’Red Bush’ is determined by a human sensoric test which is conducted by a trained tester. The flavour and taste of different batches of ‘Rooibos’/’Red Bush’ may differ but through the analysis of a large sample set, the following flavours have been proven to be present in ‘Rooibos’/’Red Bush’ to differing degrees.

                        Flavour

                        Sweet

                        Honey

                        Caramel

                        Fruity

                        Citrus

                        Berry

                        Apricot Jam

                        Woody

                        Bushy/Stemmy

                        Smokey/Burnt

                        Floral

                        Fynbos

                        Perfume

                        Spicy

                        Cinnamon

                        Taste and mouthfeel

                        Basic tastes

                        Sweet

                        Bitter

                        Sour

                        Mouthfeel

                        Soft and smooth

                        Astringent

                  3.3.   Feed (for products of animal origin only) and raw materials (for processed products only)

            The only raw material for ‘Rooibos’/’Red Bush’ is the freshly harvested leaves and stems of Aspalathus linearis.
            It contains between 0,02 and 1,16 % of aspalathin and up to 0,4 % nothofagin. Aspelathin and nothofagin will be controlled at origin according to the South African GI protection.
            3.4.   Specific steps in production that must take place in the identified geographical area

            During the production of ‘Rooibos’/’Red Bush’ the following steps must take place in the identified geographical area:

                        (a)

                        Seeds of the plant Aspalathus linearis is gathered by local seed gathers, often from ant heaps. The gatherers then supply the seeds to farmers. This is an age-old tradition still being implemented today and an essential part Rooibos cultivation as it is known today

                        (b)

                        It is commercially cultivated or grows naturally in the wild.

                        (c)

                        It is harvested from the cultivated fields (either mechanically or by hand) or from the wild (by hand only).

                        (d)

                        It is processed and dried at a tea court. The tea court may be on or off-farm, but it must be in the designated area.

                  3.5.   Specific rules concerning slicing, grating, packaging, etc. of the product the registered name refers to

            —
            3.6.   Specific rules concerning labelling of the product the registered name refers to

            ‘Rooibos’/’Red Bush’ may be blended with teas, infusions and other products, whether or not for human consumption. The labelling of such products must conform with the rules applicable to labelling of products in the territory where the product is marketed.
            4.   Concise definition of the geographical area

            The geographical area of production, drying and oxidation of ‘Rooibos’/’Red Bush’ is the following:

                        (a)

                        In the Western Cape Province the local municipalities of Bergrivier, Breede Valley, Cape Agulhas, Cederberg, City of Cape Town, Drakenstein, Langeberg, Matzikamma, Overstrand, Saldanha Bay, Stellenbosch, Swartland, Swellendam, Theewaterskloof and Witzenberg.

                        (b)

                        In the Northern Cape Province the local Municipality of Hantam.

                  5.   Link with the geographical area

               Geographical area

            The taste and specific composition of ‘Rooibos’/’Red Bush’ is directly related to the climate where it is grown. Cold wet winters, growth in spring and early summer and then maturity and polyphenol accumulation as the weather gets hotter and drier. It follows that, if Aspalathus linearis is grown in any other climate, it will not have the same characteristics as ‘Rooibos’/’Red Bush’ due to less polyphenol accumulation. In order to understand this causal relationship, it is important to understand the way in which Aspalathus linearis has adapted to the unique climate, soils and geography of this area.
            The geographical area in which ‘Rooibos’/’Red Bush’ naturally grows is known for its hot, dry summers and cold wet winters. Indeed, on 27 October 2015 a temperature of 48,3 oC was measured in Vredendal; the highest October temperature ever measured on earth. The rainfall in this area ranges between 380 to 635 mm per year and precipitation is predominantly during the winter months with occasional showers in early summer and late autumn. The long, hot summer months are extremely dry. The soils in the area is derived from the Table Mountain Sandstone Complex resulting in nutrient poor, coarse, sandy soils with a pH between 4,5 to 5,5. Table Mountain Sandstone is made up predominantly of quarzitic sandstone laid down between 510 and 400 million years ago. It is the hardest, and most erosion resistant layer of the Cape Supergroup.
            ‘Rooibos’/’Red Bush’ has developed some unique characteristics (i.e. shape and coating of leaves, etc.) to adapt in this harsh climate. In addition to a network of lateral roots just below the soil surface that can utilize even light precipitation, the plant has a long tap root that reaches as deep as two meters and helps the plant find moisture and reach water during the dry summers. The lateral roots enables the plant to enhance phosphorus acquisition from the soil which is among the most phosphorous impoverished in the world.
            One of the biggest secrets underlying to the adaption of ‘Rooibos’/’Red Bush’ in this harsh climate can be found in its symbiotic relationship with the nitrogen-fixating bacteria on its roots. As a legume, the bacteria on the roots of Aspalathus linearis convert nitrogen dioxide to biologically useful ammonia in a process known as nitrogen fixation. The plant absorbs the nitrogen and benefits from it in exchange for providing the bacteria with food. This process is common for legumes, but what is unique in the case of Aspalathus linearis is that the indigenous bradyrhizobia are naturally tolerant of acidity and the plant has some ability to modify its rhizosphere pH in order to promote symbiotic establishment and nutrient availability to plants growing in this otherwise infertile acidic soil. It has been reported in the literature that very few symbioses can tolerate such extremities of soil acidity and low nutrient stress whilst fixing high levels of nitrogen as exhibited by Aspalathus linearis.
            Producers of ‘Rooibos’/’Red Bush’ have taken advantage of the hot and dry summers to naturally dry the harvested material. ‘Rooibos’/’Red Bush’ is harvested each year during the hot summers and is sun dried just after harvesting. The harsh sun, with the absence of rain, allows for natural drying of ‘Rooibos’/’Red Bush’ during which the process of oxidisation can be optimally controlled.

               Human intervention

            Although the Cape Floral Region (with its distinctive ‘Fynbos’ vegetation) is the smallest of the six Floral Kingdoms of the world, it is the most diverse and it is one of the most special places in the world for plants in terms of diversity, density and the number of endemic species. However, Aspalathus linearis is one of a limited number of plants which has made a successful transition from a wild to a cultivated crop and is one of relatively few economically important fynbos plants to date; the result of human intervention.
            Almost 250 years ago Swedish naturalist Carl Thunberg reported that, during his travels in Africa in 1772, he met the local inhabitants and observed that they used ‘Rooibos’/’Red Bush’ as a beverage. ‘Rooibos’/’Red Bush’ leaves and stems were collected on the mountains and bunched into hessian bags that were carried down the steep slopes on the backs of donkeys. The basic ‘Rooibos’/’Red Bush’ processing methods that are still in use today (first cut and bruise the ‘Rooibos’/’Red Bush’ leaves and stems, then ‘sweat’ or cure the tea in heaps and finally then spread it out to dry in the sun) were developed at that time.
            Around 1930 a local Clanwilliam doctor and nature lover Le Fras Nortier became interested in ‘wild bush tea’ and started experimenting with ‘Rooibos/Red Bush’. It was difficult to find ‘Rooibos’/’Red Bush’ seeds (due to their extremely small size) and Nortier asked the local people, some of them his patients, to search for seeds in the sandy soils and collect some for him. A Khoi woman brought him a matchbox filled with seeds and later Nortier learnt her secret. The woman would follow ants that were dragging ‘Rooibos’/’Red Bush’ seeds to their nests. She then broke open the nests to collect seeds, always leaving some for the ants to survive. This way of collecting seeds is still being used by some seeds collectors.
            Looking for a way to propagate the seeds, Nortier discovered that the seeds would only germinate if they were cracked open first – imitating the effect of mountain fires. Nortier cultivated the first plants on the Klein Kliphuis farm near Clanwilliam. He learnt that the seeds should be sown in January and that the best time to transplant the tiny seedlings is just after heavy rain when more rain is due. Nortier also inspired and encouraged local farmers to start cultivating ‘Rooibos’/’Red Bush’.
            These practices of seed collection and scouring of seeds are still being used today and Aspalathus linearis is produced under dry land conditions as the plant is adapted to dry, hot summers. These environmental conditions influence the chemical composition of ‘Rooibos’/’Red Bush’, in particular the level and type of polyphenols found in the final product. ‘Rooibos’/’Red Bush’ producers have adapted their land management and cultivation practices to the harsh conditions of the region. For instance, fire cannot be used to clear areas for cultivation as it destroys the organic content of the soil. Furthermore, cover crops plays an important role during various stages of the cultivation process and minimum or conservation tillage is a common practice.
            Harvesting takes place during the dry summer months of November to May and 20 % of the plant material must be left on the plant. The freshly harvested material must reach the tea court within 72 hours of being harvested and a mechanical cutter is used to reduce the stems and leaves so that they are between 1 and 10 mm in length. In the case of oxidised ‘Rooibos’/’Red Bush’ the freshly cut material is then exposed to the sun in row-like heaps on the concrete or rock surface of the tea court. The rows are wetted, the leaves bruised and the rows turned at regular intervals until the right consistency is reached after which it is spread thinly on the tea court to dry. In the case of unoxidised (green) ‘Rooibos’/’Red Bush’ the leaves and stems are thinly spread on the tea court straight after it was cut into 1-10 mm lengths.
            The tea court process is often described as an art form and is one of the most critical parts of the ‘Rooibos’/’Red Bush’ production process with specific know-how and expertise required. The tea maker carefully watches the colour, texture and moistness of the tea until the desired soapy feel is attained. A typical method is to take a handful of the wet, bruised tea and squeeze it until the hand forms a fist, and if the moisture level is correct, a tiny trickle of juice runs through the gaps between the base of the fingers.
            Expert graders evaluate the quality of ‘Rooibos’/’Red Bush’ according to a number of factors, including the colour of the dry and infused leaves, the intensity, colour and clarity of the infusion, as well as the flavour and taste. Trained sensory panels are used to judge taste and flavour. A sensory wheel has been developed and is a valuable tool to facilitate communication among ‘Rooibos’/’Red Bush’ producers, processors, grading experts, marketers, flavour houses, importers and consumers. To aid interpretation of the descriptors a preliminary sensory lexicon for some of the descriptors have also been developed.

               Specificity of the product

            The unique sensory characteristics (or flavour and mouth-feel) of ‘Rooibos’/’Red Bush’ has been described above. These descriptors are based on analysis of a large sample set and captures the sensory fingerprint of ‘Rooibos’/’Red Bush’.
            These unique sensory characteristics of ‘Rooibos’/’Red Bush’ can be ascribed to the complex phenolic chemistry of Aspalathus linearis. The flavonoid composition of ‘Rooibos’/’Red Bush’ is unique in that it contains aspalathin and aspalalinin, as well as the rare compounds nothofagin and enolicphenylpyruvic acid glucoside. Whereas most of the flavonoids occur ubiquitously in the plant kingdom, until now aspalathin has only been detected in Aspalathus linearis, creating it’s unique sensory characteristics.
            It was noted in the previous section that the use of the dried leaves and stems of ‘Rooibos’/’Red Bush’ as a tea was first documented almost 250 years ago. Since then its fruity, sweet taste with caffeine free low tannin status has resulted in it being a cultural icon of South Africa. Surveys conducted in 2005 showed that ‘Rooibos’/’Red Bush’ tea was one of the ten most frequently consumed foods in an informal settlement in South Africa.

               Reference to publication of the specification

            (the second subparagraph of Article 6(1) of this Regulation)
            —


title: Commission Implementing Regulation (EU) 2021/875 of 25 May 2021 entering a name in the register of protected designations of origin and protected geographical indications (‘Sõir’ (PGI))

text:
                  1.6.2021

                  EN

                  Official Journal of the European Union

                  L 192/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/875
         of 25 May 2021
         entering a name in the register of protected designations of origin and protected geographical indications (‘Sõir’ (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, Estonia’s application to register the name ‘Sõir’ 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 ‘Sõir’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Sõir’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.4. – Other products of animal origin, 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, 25 May 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 46, 9.2.2021, p. 10.

            (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) 2021/876 of 31 May 2021 laying down rules for the application of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for the uses of substances in the production of legacy spare parts and in the repair of articles and complex products no longer produced and amending Regulation (EC) No 340/2008 (Text with EEA relevance)

text:
                  1.6.2021

                  EN

                  Official Journal of the European Union

                  L 192/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/876
         of 31 May 2021
         laying down rules for the application of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for the uses of substances in the production of legacy spare parts and in the repair of articles and complex products no longer produced and amending Regulation (EC) No 340/2008
         (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 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 74(1) and 132 thereof,
         Whereas:

                     (1)

                     Article 56(1) of Regulation (EC) No 1907/2006 sets out an authorisation requirement for the placing on the market and the use of substances of very high concern listed in Annex XIV to that Regulation. The compliance with that requirement, in certain cases, constitutes a significant administrative burden for undertakings. In its Communication of 18 June 2014‘Regulatory Fitness and Performance Programme (REFIT): State of Play and Outlook’ (2) the Commission announced that it was considering simplifying the authorisation process in some specific cases. Simplifying the applications for continued use of substances of very high concern in the production of legacy spare parts was identified as one of the actions in the Commission Communication of 5 March 2018‘Commission General Report on the operation of REACH and review of certain elements’ (3).

                     (2)

                     The Commission Communication of 2 December 2015‘Closing the loop – An EU action plan for the Circular Economy’ (4) describes that the extension of the lifetime of products by way of repair helps avoid wastage. The Council conclusions of 20 June 2016 on that action plan (5) invite the Commission to investigate what initiatives can be taken at Union level in the interest of extending the lifetime of products, in particular by promoting the availability of spare parts.

                     (3)

                     In order to avoid the premature obsolescence of articles or complex products (6) that are no longer produced after the sunset dates referred to in Annex XIV to Regulation (EC) No 1907/2006, spare parts as well as substances and mixtures that are necessary for the repair of such articles or complex products need to continue to be made available on the market and used. If a substance listed in Annex XIV to Regulation (EC) No 1907/2006 has been used to produce such articles or complex products and, if after the sunset date the spare part cannot be produced or the product cannot be repaired without the use of that substance, the requirements as regards the content of the application for authorisation and of the review report of an authorisation for such uses should be clarified in order to simplify such applications for authorisation.

                     (4)

                     As regards the analysis of alternatives referred to in Article 62(4)(e) of Regulation (EC) No 1907/2006, providing justification demonstrating that the article or complex product is no longer produced after the sunset date, that it cannot function as intended without the spare part and that such spare part cannot be produced without the substance, or that the article or complex product cannot be repaired otherwise than by using the substance, should be considered sufficient to conclude on the lack of suitable alternatives. As the use of the substance in the production of such spare parts or repair of such articles or complex products will gradually decrease since its intended use is for a product that is no longer produced, while the substitution costs for research and development, testing, qualification, and industrialisation of possible alternatives for such uses are likely to be high in view of the expected decreasing trend, such provision is deemed justified.

                     (5)

                     Similarly, the justification demonstrating that the article or complex product is no longer produced after the sunset date, that it cannot function as intended without the spare part and that such spare part cannot be produced without the substance, or that the article or complex product cannot be repaired otherwise than by using the substance should be considered sufficient in order to demonstrate the socioeconomic benefits of the use of the substance in the socioeconomic analysis referred to in point (a) of Article 62(5) of Regulation (EC) No 1907/2006. The non-availability of spare parts or the impossibility to repair articles or complex products no longer produced without that substance would lead to the premature obsolescence of those articles or complex products before the end of their lifetime use and therefore to their premature disposal, likely causing high costs to operators, consumers or society. Moreover, the number of uses and quantities of the substance used for such spare parts are expected to decrease, leading to a diminishing impact on human health and the environment associated with the exposure to or emission of the substance used. It is therefore appropriate that contents of the socioeconomic analysis referred to in point (a) of Article 62(5) of Regulation (EC) No 1907/2006 be provided by the applicant in a succinct form. This is without prejudice to the consideration of the risk posed by the use of the substance to human health or the environment and to the need for the applicant to demonstrate that socioeconomic benefits outweigh that risk.

                     (6)

                     The clarification of the content of applications for authorisation for the use of a substance in the production of spare parts for repair or in the repair of articles and complex products no longer produced should result in a reduction of the workload for the European Chemicals Agency (‘the Agency’) in assessing applications for authorisation in those specific cases. The fees levied for such applications should be proportionate to the expected workload of the Agency in such cases and, hence, be reduced when compared to the fee levied for the applications for other uses. For the same reasons, the charges applicable to the review of authorisations granted for those uses should be reduced by the same proportion.

                     (7)

                     Commission Regulation (EC) No 340/2008 (7) should therefore be amended accordingly.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133 of Regulation (EC) No 1907/2006,

               HAS ADOPTED THIS REGULATION:

            Article 1
            This Regulation implements Articles 61(1), 62(4)(e) and 62(5)(a) of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for any of the following uses of a substance, on its own or in a mixture, listed in Annex XIV to that Regulation:

                        (a)

                        the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date for that substance specified in Annex XIV, where that substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare part cannot be produced without that substance (‘production of legacy spare parts’);

                        (b)

                        the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date for that substance specified in Annex XIV, where that substance was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance (‘repair of articles or complex products no longer produced’).

            Article 2

               1.   An application for authorisation pursuant to Article 62 of Regulation (EC) No 1907/2006 for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced shall be considered to comply with point (e) of Article 62(4) of that Regulation when it includes the following:

                           (a)

                           a description and analysis of the function of the substance; and

                           (b)

                           a justification demonstrating that the conditions set out in points (a) or (b) of Article 1 of this Regulation as appropriate have been fulfilled.

               2.   An application for authorisation pursuant to Article 62 of Regulation (EC) No 1907/2006 for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced shall be considered to comply with point (a) of Article 62(5) of that Regulation when it includes the following:

                           (a)

                           a succinct description of the human health or environmental impacts in accordance with the information provided in the chemical safety report;

                           (b)

                           a succinct description of the socioeconomic benefits of the use applied for, including a justification demonstrating that the conditions set out in points (a) or (b) of Article 1 of this Regulation as appropriate have been fulfilled;

                           (c)

                           a conclusion based on a comparison of the risks and benefits of the use of the substance applied for, as described in points (a) and (b) of this paragraph.

               3.   Where the application for authorisation is submitted for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced, information referred to in paragraphs 1 and 2 of this Article, together with any third party contributions on possible alternatives submitted in accordance with Article 64(2) of Regulation (EC) No 1907/2006, shall suffice for the purpose of assessing the socioeconomic factors and the suitability of the alternatives associated with the use of the substance.

               4.   Paragraphs 1, 2 and 3 of this Article shall apply mutatis mutandis to review reports submitted pursuant to Article 61(1) of Regulation (EC) No 1907/2006 concerning an authorisation granted for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced.

               5.   By 5 July 2021 the European Chemicals Agency (‘the Agency’) shall make publicly available specific formats for the analysis of alternatives and the socioeconomic analysis to be used in applications for authorisation for uses of substances in the production of legacy spare parts or in the repair of articles or complex products no longer produced as well as in review reports concerning an authorisation granted for such uses, submitted in accordance with this Regulation, reflecting the elements referred to in paragraphs 1 and 2.

            Article 3
            Regulation (EC) No 340/2008 is amended as follows:

                        (1)

                        in Article 8(2), the following subparagraph is added after the fourth subparagraph:
                        ‘The Agency shall levy a reduced fee as set out in point 2 of Annex VI to this Regulation for applications for authorisation for uses of substances in the production of legacy spare parts for the repair of articles or complex products no longer produced as described in point (a) of Article 1 of Commission Implementing Regulation (EU) 2021/876 (*1) and in the repair of articles or complex products no longer produced as described in point (b) of Article 1 of that Regulation, submitted in accordance with that Implementing Regulation.

                           (*1)  Commission Implementing Regulation (EU) 2021/876 of 31 May 2021 laying down rules for the application of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for the uses of substances in the production of legacy spare parts and in the repair of articles and complex products no longer produced and amending Regulation (EC) No 340/2008 (OJ 192.).’;"

                        (2)

                        in Article 9(2), the following subparagraph is inserted after the fourth subparagraph:
                        ‘The Agency shall levy a reduced charge as set out in point 2 of Annex VII to this Regulation for applications for authorisation for uses of substances in the production of legacy spare parts for the repair of articles or complex products no longer produced as described in point (a) of Article 1 of Implementing Regulation (EU) 2021/876 and in the repair of articles or complex products no longer produced as described in point (b) of Article 1 of that Regulation, submitted in accordance with that Implementing Regulation’;

                        (3)

                        Annexes VI and VII are replaced by the text as set out in the Annex to this Regulation.

            Article 4
            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, 31 May 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 396, 30.12.2006, p. 1.

            (2)  COM(2014) 368 final

            (3)  COM(2018) 116 final

            (4)  COM(2015) 614 final

            (5)  Closing the loop – An EU action plan for the Circular Economy – Council conclusions of 20 June 2016, ST 10518 2016 INIT.

            (6)  ‘Complex products’ as described in the judgment of the Court of Justice of 10 September 2015, Fédération des entreprises du commerce et de la distribution (FCD) and Fédération des magasins de bricolage et de l’aménagement de la maison (FMB), C-106/14, ECLI:EU:C:2015:576, paragraphs 48-54.

            (7)  Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 107 17.4.2008, p. 6).

            ANNEX

                     ‘ANNEX VI
                     Fees for applications for an authorisation under Article 62 of Regulation (EC) No 1907/2006

                        1.
                        Fees for applications for an authorisation

                           Table 1

                           Standard fees

                                    Base fee

                                    EUR 54 100

                                    Additional fee per substance

                                    EUR 10 820

                                    Additional fee per use

                                    EUR 48 690

                           Table 2

                           Reduced fees for medium enterprises

                                    Base fee

                                    EUR 40 575

                                    Additional fee per substance

                                    EUR 8 115

                                    Additional fee per use

                                    EUR 36 518

                           Table 3

                           Reduced fees for small enterprises

                                    Base fee

                                    EUR 24 345

                                    Additional fee per substance

                                    EUR 4 869

                                    Additional fee per use

                                    EUR 21 911

                           Table 4

                           Reduced fees for micro enterprises

                                    Base fee

                                    EUR 5 410

                                    Additional fee per substance

                                    EUR 1 082

                                    Additional fee per use

                                    EUR 4 869

                        2.
                        Fees for applications for an authorisation for uses of substances in the production of legacy spare parts or in the repair of no-longer-produced articles or complex products as referred to in the fifth subparagraph of Article 8(2)

                           Table 1

                           Standard fees

                                    Base fee

                                    EUR 27 050

                                    Additional fee per substance

                                    EUR 5 410

                                    Additional fee per use

                                    EUR 24 345

                           Table 2

                           Reduced fees for medium enterprises

                                    Base fee

                                    EUR 20 287

                                    Additional fee per substance

                                    EUR 4 057

                                    Additional fee per use

                                    EUR 18 259

                           Table 3

                           Reduced fees for small enterprises

                                    Base fee

                                    EUR 12 172

                                    Additional fee per substance

                                    EUR 2 434

                                    Additional fee per use

                                    EUR 10 955

                           Table 4

                           Reduced fees for micro enterprises

                                    Base fee

                                    EUR 2 705

                                    Additional fee per substance

                                    EUR 541

                                    Additional fee per use

                                    EUR 2 434

                     ANNEX VII
                     Charges for the review of an authorisation under Article 61 of Regulation (EC) No 1907/2006

                        1.
                        Charges for the review of an authorisation

                           Table 1

                           Standard charges

                                    Base charge

                                    EUR 54 100

                                    Additional charge per substance

                                    EUR 10 820

                                    Additional charge per use

                                    EUR 48 690

                           Table 2

                           Reduced charges for medium enterprises

                                    Base charge

                                    EUR 40 575

                                    Additional charge per substance

                                    EUR 8 115

                                    Additional charge per use

                                    EUR 36 518

                           Table 3

                           Reduced charges for small enterprises

                                    Base charge

                                    EUR 24 345

                                    Additional charge per substance

                                    EUR 4 869

                                    Additional charge per use

                                    EUR 21 911

                           Table 4

                           Reduced charges for micro enterprises

                                    Base charge

                                    EUR 5 410

                                    Additional charge per substance

                                    EUR 1 082

                                    Additional charge per use

                                    EUR 4 869

                        2.
                        Charges for the review of an authorisation granted for uses of substances in the production of legacy spare parts or in the repair of no-longer-produced articles or complex products as referred to in the fifth subparagraph of Article 9(2)

                           Table 1

                           Standard charges

                                    Base charge

                                    EUR 27 050

                                    Additional charge per substance

                                    EUR 5 410

                                    Additional charge per use

                                    EUR 24 345

                           Table 2

                           Reduced charges for medium enterprises

                                    Base charge

                                    EUR 20 287

                                    Additional charge per substance

                                    EUR 4 057

                                    Additional charge per use

                                    EUR 18 259

                           Table 3

                           Reduced charges for small enterprises

                                    Base charge

                                    EUR 12 172

                                    Additional charge per substance

                                    EUR 2 434

                                    Additional charge per use

                                    EUR 10 955

                           Table 4

                           Reduced charges for micro enterprises

                                    Base charge

                                    EUR 2 705

                                    Additional charge per substance

                                    EUR 541

                                    Additional charge per use

                                    EUR 2 434

               ’


title: Commission Implementing Regulation (EU) 2021/882 of 1 June 2021 authorising the placing on the market of dried Tenebrio molitor larva 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:
                  2.6.2021

                  EN

                  Official Journal of the European Union

                  L 194/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/882
         of 1 June 2021
         authorising the placing on the market of dried Tenebrio molitor larva 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 13 February 2018, the company SAS EAP Group (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place dried Tenebrio molitor larva (yellow mealworm) on the Union market as a novel food. The application requested for dried Tenebrio molitor larva to be used as whole, dried insect in the form of snacks, and as a food ingredient in a number of food products, the target population being the general population. The applicant also made a request to the Commission for the protection of proprietary data submitted in the application.

                     (4)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 3 July 2018, asking it to provide a scientific opinion by carrying out an assessment for dried Tenebrio molitor larva as a novel food.

                     (5)

                     On 24 November 2020, the Authority adopted a scientific opinion on the safety of Tenebrio molitor larva as a novel food (3), in accordance with Article 11 of Regulation (EU) 2015/2283.

                     (6)

                     In its opinion, the Authority concluded that dried Tenebrio molitor larva is safe under the proposed uses and use levels. Therefore, the opinion of the Authority gives sufficient grounds to establish that dried Tenebrio molitor larva under the assessed conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (7)

                     In that opinion, the Authority also concluded on the basis of limited published evidence on food allergy related to insects and in particular from two studies in humans where a total of four suspect allergic reactions were attributed to dried Tenebrio molitor larva and one study in animals, that consumption of this novel food may trigger sensitisation to yellow mealworm proteins as well as to tropomyosin from other sources such as crustaceans and mites. The Authority recommended carrying out further research on the allergenicity of dried Tenebrio molitor larva. To address the Authority’s recommendation the Commission is currently exploring the ways to carry out the necessary research on the allergenicity of Tenebrio molitor larvae.

                     (8)

                     Until the data generated by the research is assessed by the Authority, and considering that, to date, only the abovementioned few allergic cases have been reported according to data available to the insect industry of dried Tenebrio molitor larva (4), the Commission considers that no specific labelling requirements concerning the potential of dried Tenebrio molitor larva to cause primary sensitization should be included in the Union list of authorised novel foods.

                     (9)

                     The Authority in its opinion also considered that the consumption of dried Tenebrio molitor larva may cause allergic reactions to persons that are allergic to crustaceans and dust mites. Furthermore, the Authority noted that additional allergens may end up in the novel food, if these allergens are present in the substrate fed to the insects. This may include allergens, listed in the Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council (5). Therefore, it is appropriate that dried Tenebrio molitor larva made available to the consumer as such and foods containing dried Tenebrio molitor larva are appropriately labelled following the requirements in accordance with Article 9 of Regulation (EU) 2015/2283 and Regulation (EU) No 1169/2011.

                     (10)

                     In its opinion, the Authority noted that its conclusion on the safety of the novel food was based on analyses of contaminants in the novel food (6), a detailed description of the drying process (7), analytical data on chitin levels (8), and data on the oxidative and microbiological status of the novel food during storage (9). It also noted that it could not have reached that conclusion without the data from the unpublished reports of the studies contained in the applicant’s file.

                     (11)

                     The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those studies and to clarify their claim to an exclusive right of reference to those studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

                     (12)

                     The applicant declared that they held proprietary and exclusive right of reference to analyses of contaminants in the novel food, the detailed description of the drying process, the analytical data on chitin levels, and the data on the oxidative and microbiological status of the novel food during storage, at the time they submitted the application and that therefore third parties cannot lawfully access, use or refer to those studies.

                     (13)

                     The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the specific studies on analyses of contaminants in the novel food, the detailed description of the drying process, the analytical data on chitin levels, and the data on the oxidative and microbiological status of the novel food during storage, contained in the applicant’s file, on which the Authority based its conclusion on the safety of the novel food and without which it could not have assessed the novel food, should not be used for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, only the applicant should be authorised to place dried Tenebrio molitor larva on the market within the Union during that period.

                     (14)

                     However, restricting the authorisation of dried Tenebrio molitor larva and the reference to the studies contained in the applicant’s file for the sole use of the applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food, provided that their application is based on legally obtained information supporting such authorisation.

                     (15)

                     The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

                     (16)

                     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.   Dried Tenebrio molitor larva, 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.   For a period of five years from the date of entry into force of this Regulation, only the initial applicant:

                           Company: SAS EAP Group;

                           Address: 35 Boulevard du Libre Échange, 31650 Saint-Orens-de-Gameville, France,

                           is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of SAS EAP Group.

               3.   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 studies contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of SAS EAP Group.

            Article 3
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 4
            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, 1 June 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)  Safety of dried yellow mealworm (Tenebrio molitor larva) as a novel food pursuant to Regulation (EU) 2015/2283; EFSA Journal 2021:19(1):6343.

            (4)  Tenebrio molitor larva is marketed in a number of Member States under the transitional measures laid down in Article 35(2) of Regulation (EU) 2015/2283.

            (5)  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).

            (6)  SAS EAP Group 2016 (unpublished).

            (7)  SAS EAP Group 2013 (unpublished).

            (8)  SAS EAP Group 2018 (unpublished).

            (9)  SAS EAP Group 2020 (unpublished).

            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 in alphabetical order:

                                    Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    Data protection

                                    ‘Dried Tenebrio molitor larva (yellow mealworm)

                                       Specified food category

                                       Maximum levels

                                                1.

                                                The designation of the novel food on the labelling of the foodstuffs containing it shall be “Dried Tenebrio molitor larva (yellow mealworm)”.

                                                2.

                                                The labelling of the foodstuffs containing dried Tenebrio molitor larva (yellow mealworm) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans and products thereof, and to dust mites. This statement shall appear in close proximity to the list of ingredients.

                                    Authorised on 22 June 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: SAS EAP Group, 35 Boulevard du Libre Échange, 31650 Saint-Orens-de-Gameville, France.
                                    During the period of data protection, the novel food is authorised for placing on the market within the Union only by SAS EAP Group, unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283, or with the agreement of SAS EAP Group.
                                    End date of the data protection: 22 June 2026.’

                                    Dried Tenebrio molitor larva, whole or in powder

                                    Protein products

                                    10 g/100 g

                                    Biscuits

                                    10 g/100 g

                                    Legumes-based dishes

                                    10 g/100 g

                                    Pasta-based products

                                    10 g/100 g

                        (2)

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

                                    Authorised Novel Food

                                    Specification

                                    ‘Dried Tenebrio molitor larva (yellow mealworm)

                                       Description/Definition:

                                    The novel food is the whole, thermally dried yellow mealworm, either whole (blanched, oven-dried larva) or in the form of a powder (blanched, oven-dried, ground larva). The term “mealworm” refers to the larval form of Tenebrio molitor, an insect species that belongs to the family of Tenebrionidae (darkling beetles).
                                    The entire mealworms are meant for human consumption and no parts are removed.
                                    A minimum 24 hours fasting period is required before the thermal drying step, to allow the larvae to discard their bowel content.

                                       Characteristics/Composition:

                                                Ash (% w/w): 3,5 – 4,5

                                                Moisture (% w/w): 1-8

                                                Crude protein (N x 6,25) (% w/w): 56–61

                                                Digestible Carbohydrates (*1) (% w/w): 1–6

                                                Fat (% w/w): 25–30

                                                of which saturated (% w/w): 4–9

                                                Peroxide value (Meq O2/kg fat): ≤ 5

                                                Dietary fibre (% w/w): 4–7

                                                Chitin (% w/w): 4–7

                                       Heavy metals:

                                                Lead: ≤ 0,075 mg/kg

                                                Cadmium: ≤ 0,1 mg/kg

                                       Mycotoxins:

                                                Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kg

                                                Aflatoxin B1: ≤ 2 μg/kg

                                                Deoxynivalenol: ≤ 200 μg/kg

                                                Ochratoxin A: ≤ 1 μg/kg

                                       Microbiological criteria:

                                                Total aerobic colony count: ≤ 105 CFU (*2)/g

                                                Yeasts and moulds: ≤ 100 CFU/g

                                                   Escherichia coli: ≤ 50 CFU/g

                                                   Salmonella spp.: Not detected in 25 g

                                                   Listeria monocytogenes: Not detected in 25 g

                                                Sulfite-reducing Anaerobes: ≤ 30 CFU/g

                                                   Bacillus cereus (presumptive): ≤ 100 CFU/g

                                                Enterobacteriaceae (presumptive): < 10 CFU/g

                                                Coagulase-positive staphylococci: ≤ 100 CFU/g

               (*1)  Digestible carbohydrates = 100 – (crude protein + fat + dietary fibre + ash + moisture).

               (*2)  CFU: colony forming units.’