ddrg/super_eurlex huggingface dataset:
(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 24 April 2012 (3), 15 May 2013 (4) and 20 October 2015 (5) that, under the proposed conditions of use, allura red AC does not have an adverse effect on animal health or the environment. It also concluded that the substance should be considered potentially harmful for the user of the additive as a result of skin, eye, or inhalation exposure. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. In accordance with Commission Regulation (EC) No 429/2008 (6), phase I of the environmental risk assessment has determined that allura red AC, as an additive intended for non-food producing animals, is exempted from further assessment due to the unlikelihood of a significant environmental effect, there being no scientifically-based evidence for concern having been identified by the Authority in its above-mentioned opinions. The Authority further concluded that the additive concerned is effective in adding colour to feedingstuffs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
COMMISSION IMPLEMENTING REGULATION (EU) 2020/410

of 12 March 2020

approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications ‘Queso de Valdeón’ (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 the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Spain’s application for the approval of amendments to the specification for the protected geographical indication ‘Queso de Valdeón’, registered under Commission Regulation (EC) No 135/2004 (2).

(2) Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

(3) As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

HAS ADOPTED THIS REGULATION:

Article 1 The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Queso de Valdeón’ (PGI) are hereby approved.

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, 12 March 2020. For the Commission, On behalf of the President, Janusz WOJCIECHOWSKI Member of the Commission

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

(2) Commission Regulation (EC) No 135/2004 of 27 January 2004 supplementing the Annex to Regulation (EC) No 2400/96 on the entry of certain names in the Register of protected designations of origin and protected geographical indications (Fraise du Périgord and Queso de Valdeón) (OJ L 21, 28.1.2004, p. 9).

(3) OJ C 375, 6.11.2019, p. 30.
COMMISSION IMPLEMENTING REGULATION (EU) 2020/861

of 16 June 2020

approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications ‘Cantal’/‘fourme de Cantal’/‘cantalet’ (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(2) thereof,

Whereas:

(1) Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined France’s application for the approval of amendments to the specification for the protected designation of origin ‘Cantal’/‘fourme de Cantal’/‘cantalet’, registered under Commission Regulation (EC) No 1107/96 (2). These amendments include changing the name ‘Cantal’/‘fourme de Cantal’/‘cantalet’ to ‘Cantal’/‘Fourme de Cantal’.

(2) Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

(3) As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

HAS ADOPTED THIS REGULATION:

Article 1 The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Cantal’/‘fourme de Cantal’/‘cantalet’ (PDO) are hereby approved.

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, 16 June 2020. For the Commission, On behalf of the President, Janusz WOJCIECHOWSKI Member of the Commission

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

(2) Commission Regulation (EC) No 1107/96 of 12 June 1996 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Council Regulation (EEC) No 2081/92 (OJ L 148, 21.6.1996, p. 1).

(3) OJ C 46, 11.2.2020, p. 14.
COMMISSION IMPLEMENTING REGULATION (EU) 2020/974

of 6 July 2020

entering a name in the register of protected designations of origin and protected geographical indications ‘Pecorino del Monte Poro’ (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 Articles 15(1) and 52(2) thereof,

Whereas:

(1) Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Italy’s application to register the name ‘Pecorino del Monte Poro’ 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 ‘Pecorino del Monte Poro’ should therefore be entered in the register.

(3) By letter received on 20 January 2020, the Italian authorities notified the Commission that the company Cooperativa Fattoria della Piana Società Agricola, which is established on their territory, had been legally marketing the product sold under the name ‘Pecorino Monteporo’, using this name continuously for at least 5 years, and that this point had been noted in the national opposition procedure.

(4) Since the company Cooperativa Fattoria della Piana Società Agricola meets the requirements laid down in Article 15(1) of Regulation (EU) No 1151/2012 for the granting of a transitional period in which to make legal use of the sales name after registration, it should be granted a transitional period of 3 years in which it may use the name ‘Pecorino Monteporo’.

(5) The measures provided for in this Regulation are in accordance with the opinion of the Agricultural Product Quality Policy Committee,

HAS ADOPTED THIS REGULATION:

Article 1 The name ‘Pecorino del Monte Poro’ (PDO) is hereby entered in the register. The name specified in the first paragraph denotes a product in Class 1.3 – Cheeses, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

Article 2 The company Cooperativa Fattoria della Piana Società Agricola is authorised to continue to use the name ‘Pecorino Monteporo’ for a transitional period of 3 years from the 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, 6 July 2020. For the Commission The President Ursula VON DER LEYEN

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

(2) OJ C 333, 4.10.2019, p. 19.

(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).
(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 May 2019 (2) that, under the proposed conditions of use, the preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that exposure to users by inhalation is unlikely and that no conclusion could be drawn on skin or eyes sensitisation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that the additive has the potential to be efficacious in improving zootechnical performance in chickens for fattening and this conclusion can be extended to chickens reared for laying and to be extrapolated to minor poultry species reared for laying. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1084

of 17 July 2020

entering a name in the register of protected designations of origin and protected geographical indications ‘Südtiroler Schüttelbrot’/‘Schüttelbrot Alto Adige’ (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, Italy’s application to register the name ‘Südtiroler Schüttelbrot’/‘Schüttelbrot Alto Adige’ 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 ‘Südtiroler Schüttelbrot’/‘Schüttelbrot Alto Adige’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1 The name ‘Südtiroler Schüttelbrot’/‘Schüttelbrot Alto Adige’ (PGI) is hereby entered in the register. The name specified in the first paragraph denotes a product in Class 2.3. – Bread, pastry, cakes, confectionery, biscuits and other baker’s wares, 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, 17 July 2020. 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 81, 11.3.2020, p. 6.

(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).
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1062

of 13 July 2020

conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name ‘Csopak’/‘Csopaki’ (PDO)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 99 thereof,

Whereas:

(1) In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Csopak’/‘Csopaki’ forwarded by Hungary and has published it in the Official Journal of the European Union (2).

(2) No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(3) In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Csopak’/‘Csopaki’ should be protected and entered in the register referred to in Article 104 of that Regulation.

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

HAS ADOPTED THIS REGULATION:

Article 1 The name ‘Csopak’/‘Csopaki’ (PDO) is hereby protected.

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, 13 July 2020. For the Commission, On behalf of the President, Janusz WOJCIECHOWSKI Member of the Commission

(1) OJ L 347, 20.12.2013, p. 671.

(2) OJ C 70, 4.3.2020, p. 12.
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1120

of 23 July 2020

conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name ‘Adamclisi’ (PDO)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 99 thereof,

Whereas:

(1) In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Adamclisi’ forwarded by Romania and has published it in the Official Journal of the European Union (2).

(2) No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(3) In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Adamclisi’ should be protected and entered in the register referred to in Article 104 of that Regulation.

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

HAS ADOPTED THIS REGULATION:

Article 1 The name ‘Adamclisi’ (PDO) is hereby protected.

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, 23 July 2020. For the Commission, On behalf of the President, Janusz WOJCIECHOWSKI Member of the Commission

(1) OJ L 347, 20.12.2013, p. 671.

(2) OJ C 51, 14.2.2020, p. 46.
(3)

Certain single-use devices are not suitable for reprocessing. CS concerning risk management should therefore include the analysis of the characteristics of single-use devices in terms of construction, material, properties and planned application, in order to assess the suitability of such single-use devices for reprocessing. It is therefore necessary to determine the characteristics of single-use devices to be taken into account within risk management procedures, as to ensure the exclusion of those single-use devices that cannot safely be reprocessed due to their particular hazard potential or specific technical characteristics. Risk management should take into account the risks related to material composition, leachable material, microbiological contamination, prions and transmissible spongiform encephalopathy agents, endotoxins, pyrogenic reactions, allergic reactions and toxic reactions, to assess whether single-use device is suitable for reprocessing. The technical characteristics and geometrical properties of the products should also be taken into consideration when assessing suitability of single-use devices for reprocessing. Based on these circumstances, examples of single-use devices that could be considered unsuitable for reprocessing include the following: devices emitting radiation, devices used for administering cytostatic or radiopharmaceutical medicines, devices incorporating medicinal substances, devices for use in invasive procedures on the central nervous system, devices that pose a risk of transmission of spongiform encephalopathies, implantable devices, devices for which serious incidents have occurred after reprocessing and the cause of the incident is related to the reprocessing or it cannot be excluded that the cause of the incident is related to the reprocessing, devices with batteries which cannot be changed or present a risk of malfunctioning after reprocessing, devices with internal data storage necessary for the use of the device and which cannot be changed or presents a risk of malfunctioning after reprocessing, devices with cutting or scraping blades, drills or components wearing off that are no longer suitable after the first use and cannot be changed or sharpened before the next medical procedure.
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1289

of 9 September 2020

concerning the classification of certain goods in the Combined Nomenclature

THE EUROPEAN COMMISSION,

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 September 2020. For the Commission, On behalf of the President, Gerassimos THOMAS Director-General Directorate-General for Taxation and CustomsUnion

(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).
(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 July 2019 (2) that, under the proposed conditions of use, zinc chelate of lysine and glutamic acid does not have an adverse effect on animal health and consumer health. It also concluded that the additive is considered as a potential skin and respiratory sensitizer and stated a risk for the users of the additive upon inhalation. Therefore, appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that that additive does not pose an additional risk for the environment compared to other compounds of zinc and that it is an efficacious source of zinc for all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1321

of 17 September 2020

entering a name in the register of protected designations of origin and protected geographical indications (‘Aydın Kestanesi’ (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(2) thereof,

Whereas:

(1) In accordance with Article 50(2)(a) of Regulation (EU) No 1151/2012, Turkey’s application to register the name ‘Aydın Kestanesi’ 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 ‘Aydın Kestanesi’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1 The name ‘Aydın Kestanesi’ (PDO) 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, 17 September 2020. 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 185, 4.6.2020, p. 16.

(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).