Date: 2020-02-07Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2020/173 of 6 February 2020 concerning the authorisation of brilliant blue FCF as a feed additive for cats and dogs (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2020/173 authorises brilliant blue FCF as a sensory feed additive (colourant) for cats and dogs. It classifies the additive under sensory additives and functional group colourants. The regulation includes transitional measures allowing the continued use of existing stocks produced and labelled under previous rules until exhausted, with specific deadlines of August 27, 2020, and February 27, 2022, for different stages of the feed production and distribution chain. The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Authorisation:**
* Brilliant blue FCF is authorised as a feed additive for cats and dogs under the category of sensory additives (colourants).
* The substance is specified in the Annex, outlining its composition, identification number (2a133), and other provisions.
* **Conditions of Use:**
* The maximum content of brilliant blue FCF is set at 278 mg/kg for cats and 334 mg/kg for dogs, calculated in complete feedingstuff with a moisture content of 12%.
* Directions for use of the additive and premixture must indicate storage conditions and stability to heat treatment.
* Users must establish operational procedures and organisational measures to address potential risks. If risks cannot be minimised, personal protective equipment (eye, skin, and breathing protection) must be used.
* **Purity Criteria and Analytical Methods:**
* Specifies purity criteria for brilliant blue FCF, including content of total colouring matters, water-insoluble matter, subsidiary colouring matters, and limits for organic compounds and other substances.
* Outlines analytical methods for quantification of total colouring matters content in the feed additive and for quantification of brilliant blue in feedingstuffs, referencing spectrophotometry and high-performance liquid chromatography coupled to tandem mass spectrometry (LCMSMS).
* **Transitional Measures:**
* Substances and premixtures produced and labelled before August 27, 2020, can continue to be placed on the market and used until existing stocks are exhausted.
* Feed materials and compound feed produced and labelled before February 27, 2022, can continue to be placed on the market and used until existing stocks are exhausted.
Impact Analysis:
Feed Additive Manufacturers/Producers:
* Impact: Must comply with the new authorisation conditions for brilliant blue FCF, including revised labelling requirements and maximum content levels.
* Action Required: Update production processes and labelling to meet the new standards by the specified deadlines.
Feed Business Operators (including users of the additive):
* Impact: Responsible for establishing operational procedures and organisational measures to mitigate potential risks to human health when using brilliant blue FCF.
* Action Required: Implement appropriate risk management procedures, including the potential use of personal protective equipment, and ensure compliance with storage and stability guidelines.
Member States:
* Impact: Responsible for ensuring the regulation is implemented and enforced within their jurisdiction.
* Action Required: Incorporate the regulation into national law and monitor compliance.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, outlining the scope of the EU's powers.
Regulation EC No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
European Parliament: The parliamentary body of the European Union.
Council Directive 70/524/EEC: A Council Directive concerning additives in feedingstuffs.
Brilliant blue FCF: A synthetic organic food dye, classified as a sensory additive and colourant for animal nutrition.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
7.2.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 35/9
COMMISSION IMPLEMENTING REGULATION (EU) 2020/173
of 6 February 2020
concerning the authorisation of brilliant blue FCF as a feed additive for cats and dogs
(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 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(2) of Regulation (EC) No 1831/2003 provides
for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2)
(2) Brilliant blue FCF was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for
dogs and cats belonging to the group ‘colourants, including pigments’, under the heading ‘colouring agents
authorised for colouring foodstuffs by Community rules’. The 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 in conjunction with Article 7 thereof, an
application was submitted for the re-evaluation of brilliant blue FCF as a feed additive for dogs and cats. The
applicant requested the additive to be classified in the additive category ‘sensory additive’ and in the functional
group ‘colourants’. The application was accompanied by the particulars and documents required under Article 7(3)
of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 June 2013(3) that, under the
proposed conditions of use, brilliant blue FCF does not have an adverse effect on animal health. It also concluded
that the substance should be regarded as an inhalation hazard for the user of the additive and that in absence of data
on skin and eye irritancy it could be considered as being potentially irritating to skin and/or 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. In accordance with Commission Regulation (EC) No
429/2008(4), phase I of the environmental risk assessment has determined that Brilliant Blue FCF, 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 opinion. 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.
(5) The assessment of brilliant blue FCF shows that the conditions for authorisation, as provided for in Article 5 of
Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that additive should be authorised as specified
in the Annex to this Regulation.
(1) OJ L 268, 18.10.2003, p. 29.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3) EFSA Journal 2013; 11(7):3288.
(4) Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No
1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the
assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).L 35/10 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 7.2.2020
(6) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation
of the substance concerned, it is appropriate to allow a transitional period for interested parties 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 substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group
‘colourants’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Transitional measures
1. The substance specified in the Annex and premixtures containing that substance, which are produced and labelled
before 27 August 2020 in accordance with the rules applicable before 27 February 2020 may continue to be placed on the
market and used until the existing stocks are exhausted.
2. Feed materials and compound feed containing the substance specified in the Annex which are produced and labelled
before 27 February 2022 in accordance with the rules applicable before 27 February 2020 may continue to be placed on
the market and used until the existing stocks are exhausted.
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, 6 February 2020.
For the Commission
The President
Ursula VON DER LEYENANNEX
Minimum Maximum
content content
Identifica-
Species or
tion number Composition, chemical formula, Maximum End of period of
Additive category of mg of active substance of Other provisions
of the description, analytical method age authorisation
animal kg of complete
additive
feedingstuff with a
moisture content of 12 %
Category: Sensory additives. Functional group: Colourants. (i) substances that add or restore colour in feedingstuffs
2a133 Brilliant Blue FCF Additive composition: Cats — — 278 1. In the directions for use of the 27 February 2030
additive and premixture, the
Brilliant Blue FCF described as the sodium storage conditions and stability
salt as the principal component. Dogs — — 334 to heat treatment shall be indi
Solid form (powder) cated.
———————————— 2. For users of the additive and
Characterisation of the active sub premixtures, feed business op
stance as the sodium salt: erators shall establish opera
Disodium α-(4-(N-ethyl-3-sulphonatoben tional procedures and organisa
zylamino) phenyl)-α-(4-N-ethyl-3-sulpho tional measures to address
natobenzylamino) cyclohexa-2,5-dienyli potential risks resulting from
dene) toluene-2- sulphonate its use. Where those risks can
The calcium and the potassium salts are not be eliminated or reduced to
also permitted. a minimum by such procedures
Chemical formula: C H N Na O S and measures, the additive and
37 34 2 2 9 3
Solid form (powder) produced by chemical premixtures shall be used with
synthesis personal protective equipment,
CAS number: 3844-45-9 including eye, skin and breath
ing protection.
Purity criteria
Content not less than 85 % total colouring
matters, calculated as the sodium salt (as
say)
Water insoluble matter: ≤ 0,2 %
Subsidiary colouring matters: ≤ 6 %
Organic compounds other than
colouring matters:
— Sum of 2-, 3- and 4-formyl benzene
sulfonic acids: ≤ 1,5 %
— 3-((ethyl)(4-sulfophenyl) amino)
methyl benzene sulfonic acid: ≤ 0,3 %
Leuco base: ≤ 5 %
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35/11Minimum Maximum
content content
Identifica-
Species or
tion number Composition, chemical formula, Maximum End of period of
Additive category of mg of active substance of Other provisions
of the description, analytical method age authorisation
animal kg of complete
additive
feedingstuff with a
moisture content of 12 %
Unsulfonated primary aromatic amines:
≤ 0,01 % (calculated as aniline)
Ether extractable matter: ≤ 0,2 % from a
solution of pH 7
————————————
Analytical method (1)
For the quantification of total colouring
matters content of brilliant blue FCF in
the feed additive:
Spectrophotometry at 630 nm and titra
tion with Titanous chloride as described in:
— Commission Regulation (EU) No
231/2012 referring to FAO JECFA
Combined Compendium for Food Ad
ditive Specifications (Analytical meth
ods Vol. 4); and the Monograph No 1
(2006) ‘Brilliant Blue FCF’.
For the quantification of brilliant blue in
feedingstuffs:
— high performance liquid chromatogra
phy coupled to tandem mass spectro
metry (LC-MS/MS)
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
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