LegalizeCommission Implementing Regulation (EU) 2019/1947 of 22 November 2019 concerning the authorisation of cassia gum as a feed additive for cats and dogs (Text with EEA relevance)
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| 26.11.2019 | EN | Official Journal of the European Union | L 304/7 |
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition 1, and in particular Article 9(2) thereof,
Whereas:
- (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC 2.
- (2) Cassia gum was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for cats and dogs 3. 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.
- (3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 four applications were submitted for the re-evaluation of cassia gum as a feed additive for cats and dogs. The applicants requested this additive to be classified in the additive category ‘technological additives’ and in the functional group ‘gelling agents’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. Subsequently, three of those applications were withdrawn by the respective applicants for authorisation.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 29 October 2014 4, 25 January 2017 5 and 27 November 2018 6 that, only purified (isopropanol extraction) semi-refined cassia gum that meets the specifications of cassia gum as a food additive 7 (< 0,5 mg anthraquinones/kg) does not have an adverse effect on animal health at a maximum content of 13 200 mg/kg of complete feed with 12 % moisture content. It also concluded that the additive is regarded as a skin and respiratory sensitiser and as potential irritant to skin and eyes. 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. It further concluded that the mutagenicity of the existing semi-refined cassia gum in the market, as described in the application cannot be excluded. The Authority further concluded that cassia gum has the potential to be effective as gelling agent when used together with carrageenan in feeds with a moisture content higher than 20 %. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
- (5) The assessment of cassia gum shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied, provided that the specifications as a food additive are met. Accordingly, the use of the additive should be authorised as specified in the Annex to this Regulation.
- (6) Therefore, cassia gum as an existing product which does not comply with the specifications as a food additive, as well as feed containing it, should be withdrawn from the market. For practical reasons however, a limited period should be allowed for the withdrawal from the market of the existing stocks of the additive and feed containing it in order to enable operators to prepare themselves to meet the new requirements resulting from the authorisation.
- (7) 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
Authorisation
The additive specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘gelling agents’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Transitional measures
The feed additive cassia gum which is produced and labelled before 16 December 2019 in accordance with the rules applicable before 16 December 2019 may continue to be placed on the market and used until 16 March 2020.
Premixtures containing the feed additive referred to in paragraph 1 which are produced and labelled before 16 March 2020 in accordance with the rules applicable before 16 December 2019 may continue to be placed on the market and used until 16 June 2020.
Compound feed and feed materials containing the feed additive referred to in paragraph 1 or premixtures referred to in paragraph 2 which are produced and labelled before 16 June 2020 in accordance with the rules applicable before 16 December 2019 may continue to be placed on the market and used until 16 December 2020.
Article 3
Entry into force
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, 22 November 2019.
For the Commission
The President
Jean-Claude JUNCKER
Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs
Commission Directive 93/55/EEC of 25 June 1993 amending Council Directive 70/524/EEC concerning additives in feedingstuffs (OJ L 206, 18.8.1993, p. 11).
EFSA Journal 2014; 12(11):3899, 3900, 3901 and 3902
EFSA Journal 2017; 15(2):4709 and 4710
EFSA Journal 2019;17(1):5528.
Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).
ANNEX
| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | mg of additive/kg of complete feedingstuff with a moisture content of 12 % | mg of additive/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation |
| Additive category: technological additives. Functional group: gelling agents | Additive category: technological additives. Functional group: gelling agents | Additive category: technological additives. Functional group: gelling agents | Additive category: technological additives. Functional group: gelling agents | Additive category: technological additives. Functional group: gelling agents | Additive category: technological additives. Functional group: gelling agents | Additive category: technological additives. Functional group: gelling agents | Additive category: technological additives. Functional group: gelling agents | Additive category: technological additives. Functional group: gelling agents |
| 1f499 | Cassia gum | Additive composition: Preparation of purified endosperm of Cassia tora, Cassia obtusifolia (Leguminosae) containing less than 0,05 % Cassia occidentalis. Anthraquinones (total) < 0,5 mg/kg Powder form Characterisation of active substance: Mainly 1,4-β-D-mannopyranose units with 1,6-linked α-D-galactopyranose units. Ratio mannose to galactose is 5:1. Galactomannans > 75 % Analytical method [^ntr1-L_2019304EN.01000901-E0001]: For the determination of cassia gum in feed additive: FAO JECFA monograph No 109 as referred in Commission Directive 2010/67/EU10 | Dogs Cats | - | - | 13 200 | 1. The additive shall be only used in complete feed having a moisture content > 20 % in combination with carrageenan (representing at least 25 % of the amount of cassia gum used). 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protections. | 16.12.2029 |
Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
FAO JECFA Combined Compendium of Food Additive Specifications, ‘Cassia Gum’, Monograph No 10 (2010) http://www.fao.org/fileadmin/user_upload/jecfa_additives/docs/monograph10/additive-513-m10.pdf
Commission Directive 2010/67/EU of 20 October 2010 amending Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners (OJ L 277, 21.10.2010, p. 17).
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