The Food Additives (Scotland) Amendment (No.2) Regulations 2011

Who will this consultation be of most interest?
Manufacturers of food colours, food manufacturers using food colours and enforcement authorities.

What is the subject of this consultation?
National Regulations relating to Scotland 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 (Scotland) Amendment (No.2) Regulations 2011, which would implement the Directive in Scotland.

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 European Union 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 (Scotland) Amendment (No.2) Regulations 2011, which would implement the Directive in Scotland. Separate consultations are being carried out in England, Wales and Northern Ireland on draft Regulations relating to those parts of the United Kingdom.

Draft Regulations

The draft Food Additives (Scotland) Amendment (No.2) Regulations 2011 are attached at Annex B. These Regulations would implement the Commission Directive by making amendments to the Food Additives (Scotland) Regulations 2009 (S.S.I. 436), 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

Key proposal:

• Implementation of the Commission Directive 2011/3/EU in Scotland by means of national Regulations to amend the Food Additives (Scotland) Regulations 2009 (S.S.I 436) 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.

As part of a UK-wide exercise, the FSA in Scotland consulted industry whilst 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 in Scotland has not prepared a Business and Regulatory Impact Assessment (BRIA) on this occasion. Should this consultation bring to light any new impacts, the FSA in Scotland will reconsider the need for a BRIA.

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:

1. Do you agree with the key proposals detailed above?
2. What are the costs and benefits associated with the key proposals?
3. Do you think that the Regulations, if enacted as drafted, would achieve these aims?

The Food Standards Agency in Scotland would welcome any comments on this proposal and in particular on the key questions set out above.

• 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 are requested by close of business on Tuesday 3 May 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).

This consultation has been prepared in accordance with the HM Government Code of Practice on Consultation, which states that a consultation must follow better regulation best practice, including carrying out an Impact Assessment (Regulatory Impact Assessment in Scotland). The assessment is included in the consultation documents.

We are interested in what you thought of this consultation and would therefore welcome your general feedback on both the consultation package and overall consultation process. If you would like to assist us to improve the quality of future consultations, please feel free to share your thoughts with us by using the consultation feedback questionnaire.

In accordance with the FSA principle of openness we shall keep a copy of the completed consultation and responses, to be made available to the public on request. The FSA will publish a summary of responses, which may include personal data, such as your full name. Disclosure of any other personal data would be made only upon request for the full consultation responses. If you do not want this information to be released, please complete and return the Publication of Personal Data Form. Return of this form does not mean that we will treat your response to the consultation as confidential, just your personal data.

Within three months of a consultation ending we aim to publish a summary of responses received and provide a link to it from this page.

If, after three months, the summary is still not showing, please contact the person who was responsible for the original consultation. Alternatively, you can contact the FSA Consultation Co-ordinator by email: consultationcoordinator@foodstandards.gsi.gov.uk