FSA Consultation, 23 March 2011

ADDITIVES – FSA Consultation on The Food Additives (England) (Amendment) (No.2) Regulations 2011

A copy of the consultation document is available on this site. See: Food Additive Amendment Consultation

To provide stakeholders with an opportunity to comment on the provisions of Commission Directive 2011/3/EU and on the draft Food Additives (England) (Amendment) (No.2) Regulations 2011, which would implement the Directive in England. Responses are requested by: 20 April 2011

Audience

Who will this consultation be of most interest to?

• Manufacturers of food colours, food manufacturers using food colours and enforcement authorities.

What is the subject of this consultation?

• National regulations relating to England to implement European Commission Directive 2011/3/EU. This directive revises the purity criteria for the sole source of lycopene previously permitted for use (obtained from tomatoes) and permits the use of, and sets purity criteria for, two additional sources of lycopene (synthetic lycopene and lycopene from the fungus Blakeslea trispora).

What is the purpose of this consultation?

• To provide stakeholders with an opportunity to comment on the provisions of the Commission directive and on the draft Food Additives (England) (Amendment) (No.2) Regulations 2011, which would implement the directive in England.

Consultation details

In 2007, the European Food Safety Authority (EFSA) assessed available information on the safety of the use of lycopene as a food colour from all sources, specifically (a) solvent extraction of the natural strains of red tomatoes, (b) synthetic lycopene and (c) lycopene from Blakeslea trispora.

In its opinion, published in early 2008, EFSA reaffirmed the safety of lycopene from tomatoes for use as a food colour and gave a favourable opinion on the safety of the other two sources for such use.

Amendments are necessary to the purity criteria set down in EU legislation for lycopene obtained from tomatoes to reflect changes in industry practice and changes to international standards.

The European Commission Directive

In July 2009, the European Commission issued a proposal to make amendments to Directive 2008/128/EC (purity criteria for food colours) in order to (a) adjust the purity criteria for lycopene obtained from tomatoes, and (b) set purity criteria for, and permit the use of, the two sources of lycopene on which EFSA had given a favourable opinion.

The Commission’s proposal was adopted by Qualified Majority in the EU Standing Committee on the Food Chain and Animal Health (SCOFCAH) on 10 September 2010 and was published in the Official Journal of the EU as Commission Directive 2011/3/EU on 18 January 2011.

Purpose of Consultation

The purpose of this consultation is to provide stakeholders with an opportunity to comment on the provisions of the Commission directive and on the draft Food Additives (England) (Amendment) (No.2) Regulations 2011, which would implement the directive in England. Separate consultations will be carried out in Scotland, Wales and Northern Ireland in due course on draft regulations relating to those parts of the UK.

Draft Regulations

The draft Food Additives (England) (Amendment) (No.2) Regulations 2011 are attached at Annexe B. These regulations would implement the Commission Directive by making amendments to the Food Additives (England) Regulations 2009 (S.I. 2009/3238), in accordance with the Government’s Guiding Principles for EU Legislation, so as to:

Implement the permissive element of the directive (the two new sources of lycopene) as soon as practicable

Implement the restrictive element (the revised purity criteria for lycopene from tomatoes) on the latest date for implementation stipulated in the directive of 1 September 2011.

Proposals:

Key proposal:

Implementation of the Commission Directive 2011/3/EU in England by means of national regulations to amend the Food Additives (England) Regulations 2009 (S.I. 2009/3238) which will:

• Implement the permissive element of the directive (the two new sources of lycopene) as soon as practicable
• Implement the restrictive element (the revised purity criteria for lycopene from tomatoes) on the latest date for implementation stipulated in the directive of 1 September 2011.

Consultation Process:

The FSA consulted industry while EU negotiations on the Directive were ongoing. This consultation revealed that industry can already comply with the revised specification for lycopene from tomatoes. Permitting the use of the two additional sources of lycopene will be beneficial to industry as it will be able to use these sources for the first time.

As there would be no incremental impact on UK industry arising from the implementation of the directive, the FSA has not prepared an impact assessment (IA) on this occasion. Should this consultation bring to light any new impacts, the FSA will reconsider the need for an IA.

Given the minimal impact and the intention to implement the permissive elements of the Directive as soon as practicable, this consultation is being conducted for a shortened period of four weeks.

Questions asked in this consultation

• Do you agree with the key proposals detailed above?
• What are the costs and benefits associated with the key proposals?
• Do you think that the regulations, if enacted as drafted, would achieve these aims?

Other relevant documents:

Commission Directive 2011/3/EU of 17 January 2011 amending Directive 2008/128/EC laying down specific purity criteria on colours for use in foodstuffs.

Responses:

Responses are requested by close of business on Wednesday 20 April 2011. Please state, in your response, whether you are responding as a private individual or on behalf of an organisation/company (including details of any stakeholders your organisation represents).