Notifications for European Union (1104 notifications)

The Implementing Regulation authorizes the removal of the particle size requirement in the specifications of trans-resveratrol produced from microbial sources to align its specifications with the synthetic trans-resveratrol, which has a comparable particle size profile but no particle size requirement in its specifications.

The leaves extract of Melissa officinalis L. was authorized without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of a preparation of the leaves extract of Melissa officinalis L. for all animal species. The applicant requested the additive to be classified in the additive category 'sensory additives' and in the functional group 'flavouring compounds'. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The applicant requested the preparation of the leaves extract of Melissa officinalis L. to be authorized also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorization of flavouring compounds for use in water for drinking. Therefore, the use of the preparation of the leaves extract of Melissa officinalis L. in water for drinking should not be allowed. The European Food Safety Authority ('the Authority') concluded in its opinions of 28 January 2020 and 29 September 2021 that, under the proposed conditions of use, the preparation of the leaves extract of Melissa officinalis L. does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that the exposure of users to dusts from the additive is not of concern. However, no data was provided on irritant properties for eyes or skin, thus no conclusion could be drawn on these aspects. Due to the nature of the additive, it may be assumed to be potentially both a skin and respiratory sensitiser. 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 preparation of the leaves extract of Melissa officinalis L. is recognized to flavour food and its function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

Bitter orange extract was authorized without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. The applicant requested the additive to be classified in the additive category 'sensory additives' and in the functional group 'flavouring compounds'. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of bitter orange extract for all animal species. The applicant requested bitter orange extract to be authorized also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorization of flavouring compounds for use in water for drinking. Therefore, the use of bitter orange extract in water for drinking should not be allowed. The European Food Safety Authority ('the Authority') concluded in its opinion of 23 June 2021 that, under the proposed conditions of use, bitter orange extract does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that bitter orange extract should be considered as an irritant to skin and eyes, and as a skin and respiratory sensitiser. 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 bitter orange extract is recognized to flavour food and its function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

Butylated hydroxyanisole was authorized without a time limit as a feed additive for all animal species in accordance with Council Directive 70/524/EEC. This additive has been subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of butylated hydroxyanisole as a feed additive for all animal species. The applicant has later withdrawn the application with regard to cats, due to the adoption by EFSA on 12 November 2019 of a non-favourable opinion concerning the safety of the additive for use for cats. The re‑evaluation of butylated hydroxyanisole resulted in the authorization thereof as a feed additive for all animal species except cats, by Commission Implementing Regulation (EU) 2020/1399. Article 10(5) of Regulation (EC) No 1831/2003 requires the adoption of a Regulation withdrawing from the market feed additives for which no application in accordance with Article 10(2) and (7) of that Regulation was submitted before the deadline set in those provisions, or for which an application was submitted but subsequently withdrawn. Since the applicant has withdrawn the application with regard to cats, butylated hydroxyanisole (E 320) should be withdrawn from the market as a feed additive for cats. In accordance with Article 7 of Regulation (EC) No 1831/2003, a new application was submitted for the authorization of butylated hydroxyanisole as a feed additive for cats, to be classified in the category 'technological additives' and in the functional group 'antioxidants'. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

The proposal notified in G/SPS/N/EU/526 (13 December 2021) is now adopted by Commission Regulation (EU) 2022/617 of 12 April 2022 amending Regulation (EC) No 1881/2006 as regards maximum levels of mercury in fish and salt (Text with EEA relevance) [OJ L 115, 13 April 2021, p. 60].This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorization of a preparation of Lactiplantibacillus plantarum DSM 26571. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The application concerns the authorization of the preparation of Lactiplantibacillus plantarum DSM 26571 as a feed additive for all animal species, to be classified in the additive category 'technological additives'. The European Food Safety Authority ('the Authority') concluded in its opinion of 29 September 2021 that, under the proposed conditions of use, the preparation of Lactiplantibacillus plantarum DSM 26571 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be considered a respiratory sensitiser. 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 also concluded that the preparation concerned has the potential to improve the preservation of nutrients in silage prepared with easy, moderately difficult and difficult to ensile material. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of the preparation of Lactiplantibacillus plantarum DSM 26571 shows that the conditions for authorization, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of the preparation should be authorized as specified in the Annex to this Regulation.

The Decision lays down emergency measures to prevent the introduction into the Union of foot and mouth disease through consignments of hay and straw from third countries or territories.

The text revises the part of the EU specifications of food additives related to ethylene oxide. Currently, Regulation (EU) No 231/2012 provides that ethylene oxide may not be used for sterilizing purposes in food additives. However, there is no quantified limit for the presence of ethylene oxide regarding all food additives. Recently, in the European Union, there have been several notifications concerning findings of ethylene oxide in particular in a number of food additives used for the manufacture of a variety of foodstuffs. However, it is difficult to establish whether the presence of ethylene oxide results from its use in the sterilization of the food additives in breach of Regulation No 231/2012 or from any other reason.In order to avoid those difficulties and to ensure a high level of protection of human health, it is therefore appropriate to lay down that the presence of ethylene oxide, irrespective of its origin, is not authorized for all food additives. For this purpose, a maximum limit for residues of ethylene oxide specific for food additives should be set out at the limit of quantification in those products, that is, at the validated lowest residue concentration, which can be currently quantified and reported by routine monitoring with validated control methods. This corresponds to maximum limit of 0.1 mg/kg of ethylene oxide (sum of ethylene oxide and 2-chloro-ethanol expressed as ethylene oxide) applicable to all authorized food additives.

This draft Commission Implementing Regulation designates antimicrobials or groups of antimicrobials to be reserved for the treatment of certain infections in humans. It is based on the criteria established in Commission Delegated Regulation (EU) 2021/1760 for the designation of antimicrobials to be reserved for the treatment of certain infections in humans. Such antimicrobials or groups of antimicrobials must not be used in animals in the European Union and in animals or products of animal origin to be imported into the European Union, in accordance with Article 118 of Regulation (EU) 2019/6.

Litsea berry essential oil was authorised without a time limit in accordance with Directive 70/524/EEC as feed additive for all animal species. This additive was subsequently entered in the Register of feed additives as existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of litsea berry essential oil for all animal species. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The applicant requested litsea berry essential oil to be authorised also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water fordrinking. Therefore, the use of litsea berry essential oil in water for drinking should not be allowed.

The Regulation corrects and clarifies certain inconsistencies between the provisions of Delegated Regulations (EU) 2020/686, (EU) 2020/688 and (EU) 2020/692 and the content of model certificates for movements between member States and the entry into the Union of certain species and categories of terrestrial animals and germinal products thereof laid down in Implementing Regulation (EU) 2021/403.

Lemon extract was authorized without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of a preparation of lemon extract for all animal species. The applicant requested the additive to be classified in the additive category 'sensory additives' and in the functional group 'flavouring compounds'. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The applicant requested the preparation of lemon extract to be authorized also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorization of flavouring compounds for use inwater for drinking. Therefore, the use of the preparation of lemon extract in water for drinking should not be allowed. (The European Food Safety Authority ('the Authority') concluded in its opinion of 29 September 2021 that, under the proposed conditions of use, the preparation of lemon extract does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that the preparation of lemon extract should be considered a skin and eye irritant, and a potential corrosive. 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 Regulation (EU) 2017/625 on official controls on the agri-food chain, the Commission shall, by means of implementing acts, establish lists of animals, products of animal origin, germinal products, animal by-products and derived products, composite products, hay and straw that are subject to official controls at the border control posts. The lists have been established by way of Commission Implementing Regulation (EU) 2021/632.The objective of this draft Implementing Regulation is to include certain products of animal origin and composite products into the list of goods subject to official controls at border control posts. The scope of import controls of animal by-products has been revised. Since Combined Nomenclature (CN) codes provided for in Council Regulation (EEC) No 2658/87 have been amended by Commission Implementing Regulation (EU) 2021/1832, corresponding changes have been introduced in this Regulation.

DL-malic acid, citric acid, sorbic acid and potassium sorbate, acetic acid, sodium diacetate and calcium acetate, propionic acid, sodium propionate, calcium propionate and ammonium propionate, formic acid, sodium formate, calcium formate and ammonium formate, and lactic acid and calcium lactate were authorised without a time limit as feed additives for all animal species in accordance with Directive 70/524/EEC. Those additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the re-evaluation of DL‑malic acid, citric acid produced by Aspergillus niger DSM 25794 or CGMCC 4513/CGMCC 5751 or CICC 40347/CGMCC 5343, sorbic acid and potassium sorbate, acetic acid, sodium diacetate and calcium acetate, propionic acid, sodium propionate, calcium propionate and ammonium propionate, formic acid, sodium formate, calcium formate and ammonium formate, and lactic acid produced by Bacillus coagulans (LMG S-26145 or DSM 23965), Bacillus smithii (LMG S-27890) or Bacillus subtilis (LMG S-27889) and calcium lactate as feed additives for all animal species. The applicants requested those additives to be classified in the additive category 'technological additives' and in the functional group 'preservatives' or 'acidity regulators'. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The European Food Safety Authority ('the Authority') concluded in its opinion of 29 January 2014 that, under the proposed conditions of use, DL-malic acid does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is irritant to skin, mucosae and eyes and the exposure via inhalation is a risk. 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 also concluded that it is effective as a feed preservative.

Mandarin essential oil was authorized without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. This additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of expressed mandarin essential oil for all animal species. The applicant requested expressed mandarin essential oil to be authorized for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorization of flavouring compounds for use in water for drinking. Therefore, the use of expressed mandarin essential oil in water for drinking should not be allowed. The applicant requested the additive to be classified in the additive category 'sensory additives' and in the functional group 'flavouring compounds'. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The European Food Safety Authority ('the Authority') concluded in its opinion of 5 May 2021 that, under the proposed conditions of use, expressed mandarin essential oil does not have adverse effects on animal health, consumer health or the environment. However, no conclusions could be drawn for companion animals and ornamental fish not normally exposed to citrus by-products. The Authority also concluded that expressed mandarin essential oil should be considered as a skin sensitiser and as an irritant to skin, eyes and the respiratory tract. 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 use of tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species was authorized by Commission Implementing Regulation (EU) 2021/421 for a 10-year period. The use of ginger essential oil from Zingiber officinale Roscoe as a feed additive for all animal species, ginger oleoresin from Zingiber officinale Roscoe as a feed additive for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from Zingiber officinale Roscoe as a feed additive for horses and dogs was authorized by Commission Implementing Regulation (EU) 2021/485 for a 10-year period. The use of turmeric extract, turmeric oil, turmeric oleoresin from Curcuma longa L. rhizome as feed additives for all animal species and turmeric tincture from Curcuma longa L. rhizome as a feed additive for horses and dogs was authorized by Commission Implementing Regulation (EU) 2021/551 for a 10-year period. In the Annexes to Implementing Regulations (EU) 2021/421, (EU) 2021/485 and (EU) 2021/551, an incorrect provision for the labelling of the recommended maximum content of the active substances in premixtures was inserted in the column 'Other provisions'. That provision should only apply to the additives themselves.

Petitgrain bigarade essential oil was authorized without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That additive was subsequently entered in the Register of feed additives as existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of petitgrain bigarade essential oil for all animal species. The applicant requested petitgrain bigarade essential oil to be authorized for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorization of flavouring compounds for use in water for drinking. Therefore, the use of petitgrain bigarade essential oil in water for drinking should not be allowed. The applicant requested the additive to be classified in the additive category 'sensory additives' and in the functional group 'flavouring compounds'. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

The draft Regulation establishes maximum levels for ochratoxin A in dried fruit other than dried vine fruit, certain liquorice products, dried herbs, certain ingredients for herbal infusions, certain oilseeds, pistachio nuts and cocoa powder, non-alcoholic malt beverages, date syrup and lowers the maximum level for ochratoxin A in dried vine fruit, roasted coffee and soluble coffee.

The draft Regulation establishes maximum levels for delta-9-tetrahydrocannabinol (Δ9-THC) in hemp seeds and products derived therefrom, including hemp seed oil.

The draft Regulation establishes maximum levels for hydrocyanic acid in linseed, almonds, cassava root and cassava flour.