Implementation of Commission Directive 2009/10/EC amending directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners (England)

Who will this consultation be of most interest to?
Manufacturers of food additives and enforcement authorities.

What is the subject of this consultation?
Implementation of Commission Directive 2009/10/EC amending directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners.

What is the purpose of this consultation?
To offer stakeholders the opportunity to comment on amendments to existing EU purity criteria (specifications) relating to a number of miscellaneous additives.

The purpose of EU purity criteria legislation is to ensure that each food additive meets specified compositional criteria for the manufacture and production of the substance concerned. Directive 2009/10/EC amends the purity criteria for certain additives set out in Directive 2008/84/EC, which was implemented into English law by way of the Purity Criteria for Colours, Sweeteners and Miscellaneous Food Additives (England) Regulations 2009 (S.I. 2009 No. 891).

A draft of Directive 2009/10/EC was discussed at European Commission working groups with EU Member States and adopted at Standing Committee in December 2008. The Directive, which can be accessed on the Commission’s website (see link below), is required to be implemented into Member States' national legislation by 15 February 2010. Products that do not comply with the legislation will be prohibited after this date.

A separate Statutory Instrument should not be required to implement this Directive in England. This is because Regulations currently in draft enforcing Regulation 1333/2008 on food additives (attached at Annexe B) also implement Directive 2009/10/EC and, to that end, include a definition of Directive 2008/84/EC which, when the Regulations come into force on 20 January 2010, will automatically be construed to mean Directive 2008/84/EC as amended by Directive 2009/10/EC.

The adopted text includes the following amendments:

• Maximum levels of 50mg/kg for residual formaldehyde have been introduced in the specifications for the alginates (E 400-405). In the specifications for carageenan (E 407) and Processed Euchema Seaweed (E 407a), a level of 5mg/kg has been set for the adventitious presence of formaldehyde.
• Due to natural high background levels of lead contained in raw materials in some EU Member States, in the specifications for E 526 calcium hydroxide and E 529 calcium oxide it has not been possible to align the maximum level of lead to the limit set by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Therefore the level of lead has been fixed at the lowest achievable threshold. In addition, the levels of magnesium and alkali salts for these additives have adjusted to the lowest achievable values which remain lower or equal to those set by JECFA
• In line with opinion of JECFA, the specification for E 901 beeswax has been amended to lower the maximum permitted level of lead.
• EU wide specifications for E504(i) magnesium carbonate have been adopted. The national specifications prescribed in Schedule 4 of the Miscellaneous Food Additives Regulations 1995 are redundant and have not been carried forward in the new legislation enforcing Regulation 1333/2008.
• E 230 biphenyl and E 233 thiabendazole – the specifications for these food additives have been deleted from the Directive, as they are no longer used in foodstuffs.

The following amendments have been made to take account of recent opinions of the European Food Safety Authority (EFSA):

• the specification for E 234 nisin has been amended to permit a modified production process using a sugar-based medium.
• the specification for E 412 guar gum has been amended to permit partially depolymerised guar gum to be used as a food additive. In addition, the specification has been adjusted to take into account the increased levels of salt and the possible presence of undesirable by-products that may result from the manufacturing process.
• the specification for E 905 microcrystalline wax has been amended in order to cover waxes derived from synthetic hydrocarbon feedstocks.

The purpose of this written consultation is to seek stakeholders’ views on the amendments set out above. Because we are not aware of any financial impact arising any of the above amendments, no Impact Assessment has been produced for this consultation. However, if you consider that any aspect of the new legislation will result in costs to industry or the enforcement authorities, we would welcome details of these.

After this consultation closes, the FSA will reflect on your responses before deciding how to proceed.

Responses are required by close 15 October 2009.

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.

Consultation feedback questionnaire (Word)

Consultation feedback questionnaire (pdf)

In accordance with the FSA principle of openness our Information Centre at Aviation House will hold a copy of the completed consultation. 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.

Data protection form (Word)

Data protection form (pdf)

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