To: Interested Parties (list available upon request)
Date: 4 September 2006
Reference: ADB 6/297
PUBLIC WRITTEN CONSULTATION
EUROPEAN COMMISSION PROPOSALS FOR REGULATIONS
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL:
On Food Additives (“the additives Regulation”);
On Food Enzymes (“the enzymes Regulation”);
On Flavourings and Food Ingredients with Flavouring
Properties used in and on Foods (“the flavourings
Regulation”);
Establishing a Common Authorisation Procedure for Food
Additives, Food Enzymes and Food Flavourings (“the
common procedures Regulation”)
Dear Sir/Madam
Executive Summary
1. This letter seeks your views and comments on proposals outlined
within the letter and its attachments which comprise the “Food
Improvement Agents” package of legislation.
2. The key proposals are:
 A new European Commission proposal for a Regulation that will
update the existing legislation on food additives.
 A new European Commission proposal for a Regulation that will
update the existing legislation on flavourings.
 A new European Commission proposal for a Regulation that
introduces harmonised EU legislation on enzymes for the first
time
If you have received this consultation as a paper copy and would prefer to receive consultations on
this subject by e-mail in future, please include a request to that effect in your e-mailed response,
otherwise you will still receive paper copies of consultations on this subject.
If you no longer wish to receive information on this subject please contact the person named below.
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
A new European Commission proposal for a Regulation that sets
out regulatory procedures common to the additives, flavouring
and enzymes Regulations.
Responses are required by 27 November 2006. When responding, please
state whether you are responding as a private individual or on behalf of an
organisation/company (with a brief summary of the people it represents).
All comments and views should be sent to:
Clifford Gedling
Novel Foods, Additives and Supplements Division
FOOD STANDARDS AGENCY
Room 515c Aviation House
125 Kingsway
London WC2B 6NH
Tel: 020 7276 8570
Fax: 020 7276 8514
Or by email to: [email protected]
Detail of Consultation
3. On 28 July the European Commission published proposals for European
Parliament and Council Regulations aimed at clarifying and updating the
existing legislation on food additives and flavourings and introducing new
EU-wide rules on food enzymes, together with a proposal for common
authorisation procedures for all three, based on scientific opinions from
the European Food Safety Authority (EFSA). The key elements of each of
the proposals are set out below:

For enzymes, EU-wide rules would be laid down for the evaluation,
approval and control of enzymes used in food. Currently, food enzymes
used during the processing of foods but not active in the final product
(processing aids) are not covered by EU legislation, and in the UK are
regulated under General Food Law. The draft Regulation would allow for
the establishment of a positive list of all food enzymes used in food for a
technological purpose based on favourable scientific opinions from EFSA.
The proposal also includes requirements for the labelling of food enzymes
other than those used as processing aids.

For additives, the new legislation aims to simplify and streamline the food
additive approval system laid down in Directive 89/107/EEC. The three
current Directives covering sweeteners, colours and “miscellaneous
additives” will be repealed and incorporated into the new Regulation. The
approval of new additives, and all changes to the existing legislation, are
currently required to be made under the co-decision procedure, involving
If you have received this consultation as a paper copy and would prefer to receive consultations on
this subject by e-mail in future, please include a request to that effect in your e-mailed response.
Please note that you will still receive paper copies of consultations on this subject area unless you let us
know.
If you no longer wish to receive information on this subject please contact the person named at paragraph 3
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approval by the Council and European Parliament, which is time
consuming. Under the new proposal, changes to the legislation will be
able to be made by comitology i.e. allowing the Commission to update and
add to the EU positive list of food additives, following Member State
approval at Standing Committee and a right of scrutiny by the European
Parliament. All approvals will be based on a safety evaluation carried out
by EFSA. The proposal also sets out a re-evaluation system for all
additives currently on the EU market, based on risk assessments from
EFSA, and envisages a review of the technological aspects of all current
food additive authorisations. It also includes new harmonised EU
provisions for additives used in other additives.

For flavourings, the new legislation aims to update the general rules set
out in Directive 88/388/EEC to reflect technological and scientific
developments. The proposed Regulation sets out clearer rules on
maximum levels for undesirable substances, in line with EFSA opinions.
Definitions are clarified and stricter conditions are also introduced for the
use of the term “natural”.

The proposed Regulation introducing a single common procedure for the
approval of additives, flavourings and enzymes includes a safety
evaluation by EFSA. The benefits of this common approach include
simplified legislation and more consistency in the approval procedures.
4. The purpose of this written consultation is to seek stakeholders’ views on
the attached documents detailed below:
(i) The Food Improvement Agents Package
Proposed EU Regulations on food additives, food flavourings and food
enzymes as well as a proposed Regulation on common procedures, which
are available on the European Commission’s website at the following
address:
http://ec.europa.eu/food/food/chemicalsafety/additives/prop_leg_en.htm
(ii) Regulatory Impact Assessments
Partial Regulatory Impact Assessments (RIAs) for the proposed
Regulations on additives, flavourings and enzymes, containing an
assessment of their likely impact in terms of costs and benefits. No RIA
has been produced in respect of the proposed Regulation on common
procedures since this is considered to be cost-neutral. (Annexes D to F).
5. Council Working Group discussions in Brussels on the proposals are
planned to commence under the Finnish Presidency on 20 September.
Responses before this date would be particularly welcome as they will
help to inform the UK negotiating line during discussions. However, full
account will be taken of all responses received before the consultation
deadline of 27 November .
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6. Specific questions for the consultation
Partial Regulatory Impact Assessments (RIA)
(i)
(ii)
(iii)
Do the RIAs accurately reflect the cost implications for businesses
affected by the proposed Regulations?
Are there other implications for consumers, enforcement officers
and businesses, which should be taken into account?
Is there any other information you can provide that would better
illustrate the effects of these proposals on consumers,
enforcement officers and businesses?
Small Businesses
7. The RIAs already include preliminary assessments of the impact of the
proposals on small businesses. We would particularly welcome any
comments from small firms, or trade bodies that represent small firms, as
to any further likely cost implications arising from the proposals, such as
the impact of any additional set up costs, and any additional administrative
costs.
8. Food Standards Agency (FSA) offices in Scotland, Wales and Northern
Ireland will be carrying out similar consultations
Queries
9. Enquiries relating to the contents of this letter can be addressed to:
Glynis Griffiths (additives and common procedures regulations)
Tel: 020 7276 8556
Email: [email protected]
James Ridsdale (flavourings and enzymes regulations)
Tel: 020 7276 8559
Email: [email protected]
Or mailed to the address given at the head of this letter, directed to
the names above.
Publication of personal data and confidentiality of responses
10. As the publication of responses may include personal data, such as your
full name and contact address details, please advise us of any objections
to this by fully completing and returning the Publication of Personal Data
Form (Annex B) together with your response to the consultation. Return of
this form does not mean that we will treat your response to the
consultation as confidential.
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11. In accordance with the provisions of freedom of information legislation, all
information contained in your response may be subject to publication or
disclosure. If you consider that some of the information provided in your
response should not be disclosed, you should indicate the information
concerned, request that it is not disclosed and explain what harm you
consider would result from disclosure.
12. Any automatic confidentiality disclaimer generated by your IT system will
not be considered as such a request unless you specifically include a
request, with an explanation, in the main text of your response.
Further information
13. Please feel free to pass this document to any other parties with an interest
in the subject matter, or send us their full contact details and we will
arrange for a copy to be sent to them direct. In the interests of
sustainability and economy, e-mail addresses would be welcome if
possible, as the consultation involves a number of documents.
14. A copy of this consultation letter/package is available on our website at
www.food.gov.uk where a summary of the responses received will be
published on 22 December 2006.
15. This consultation has been prepared in accordance with the Cabinet
Office’s Code of Practice on Consultation, available at: http://www.cabinetoffice.gov.uk/regulation/consultation/code.asp The Consultation Criteria
have been reproduced within Annex C.
16. For details about the consultation process (not about the content of the
consultation) please contact: Food Standards Agency Consultation Coordinator, Room 115B Aviation House, 125 Kingsway, London, WC2B
6NH. Tel: 0207 276 8630.
17. Criterion 6 of the Cabinet Office Code of Practice states that a
consultation must follow better regulation best practice, including carrying
out a Regulatory Impact Assessment (RIA). Please see the attached RIAs
in Annexes D to F.
Comments on the consultation process itself
18. 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
which is attached in Annex A.
19. If you would like to be included on future Food Standards Agency
consultations on other topics, please advise us of those subject areas that
you might be specifically interested in by using the Feedback
Questionnaire.
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20. If any of the mailing information used to send you this letter has changed,
please advise us direct using the Feedback Questionnaire.
21. Thank you on behalf of the Food Standards Agency for participating in this
public consultation.
Yours faithfully
Glynis Griffiths (additives and common procedures)
James Ridsdale (enzymes and flavourings)
Additives Branch
Novel Foods Additives and Supplements Division
Enclosed
Annex A: Consultation Feedback Questionnaire
Annex B: Publication of Personal Data Form
Annex C: Cabinet Office Consultation Criteria
Annex D: RIA – additives
Annex E: RIA – enzymes
Annex F: RIA – flavourings
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