Draft Food Labelling (Declaration of Allergens) (Scotland) Regulations
Friday 22 June 2007
The Agency seeks views of the draft Food Labelling (Declaration of Allergens) (Scotland) Regulations, on the partial regulatory impact assessment and the questions posed, on the accompanying guidance notes and on the process of implementation of legislation on the permanent exemptions of certain derived products.
All comments and views should be sent to:
Food Standards Agency Scotland
6th Floor, St. Magnus House
25 Guild Street
Tel: 01224 285165
Fax: 01224 285168
Responses are requested by: 13 September 2007
Draft Food Labelling (Declaration of Allergens) (Scotland) Regulations
The Draft Food Labelling seeks your views on amending the Food Labelling Regulations 1996 by adding lupin and molluscs to Schedule AA1. The proposed Regulation will implement Commission Directive 2006/142/EC, which amends Directive 2000/13/EC of the European Parliament and Council of 20 March 2000, on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. The Food Labelling (Declaration of Allergens) (Scotland) Regulations 2007 amend the Food Labelling Regulations 1996 by adding lupin and molluscs to Schedule AA1.
Separate but parallel legislation will be made in respect of England, Wales and Northern Ireland.
Partial Regulatory Impact Assessment
The options are set out in the attached Partial Regulatory Impact Assessment (Annex B) in respect of an amendment to the Food Labelling Regulations 1996 (as amended) (in so far as they apply in relation to Scotland). The proposed Regulations will implement in Scotland Commission Directive 2006/142/EC, which amends Directive 2000/13/EC of the European Parliament and of the Council to add molluscs and lupin to the list.
The Agency has also taken this opportunity to revise and merge the separate guidance notes on the Food Labelling (Amendment) (Scotland) (No. 2) Regulations 2004 and the Food Labelling (Amendment) (No. 3) (Scotland) Regulations 2005. The draft of the new guidance notes is at Annex C. The Agency would welcome comments on the content and clarity of this document.
Temporarily Exempt Derived Ingredients
The temporary exemptions from allergen labelling for certain derived products are due to expire on 25 November this year and it seems very likely that we will not be in a position to implement replacement legislation at this time to ensure a seamless transition. This is because the European Food Safety Authority (EFSA) is still considering the dossiers it has received to support the permanent exemption of these products.
Views are sought on the process of implementation of legislation on permanent exemptions of certain derived products.
Food Labelling (Declaration of Allergens) (Scotland) Regulations 2007
The Food Labelling (Amendment) (Scotland) (No.2) Regulations 2004, implemented Directive 2003/89/EC, which amends Directive 2000/13/EC, as regards the indication of the ingredients present in foodstuffs. These Regulations, which came into force on 26 November 2004, established a list of 12 allergens that have to be indicated on the label whenever they or their derivatives are used as deliberate ingredients in prepacked food, including alcoholic drinks.
Due to increasing concerns about the allergenicity of both lupin and molluscs, and following advice from the European Food Safety Authority, the Commission has extended the list of 12 potential food allergens to include lupin and molluscs (gastropods, bivalves or cephalopods), and products obtained from them.
The draft Food Labelling (Declaration of Allergens) (Scotland) Regulations will implement Commission Directive 2006/142/EC, of 22 December 2006, amending Directive 2000/13/EC, by adding lupin and molluscs to the list of allergens in Schedule AA1 in the Food Labelling Regulations 1996 (as amended). Separate, but parallel legislation applies in respect of England, Wales and Northern Ireland.
Temporarily exempt derived ingredients
Directive 2005/26/EC as corrected by Directive 2005/63/EC allowed temporary exemption from labelling requirements for a specific list of products derived from the listed allergenic ingredients that had been shown not to be allergenic. This temporary exemption, which expires on 25 November 2007, was implemented into national legislation in Scotland by the Food Labelling (Amendment) (No. 3) (Scotland) Regulations 2005 and by parallel Regulations in England, Northern Ireland and Wales.
There are a number of possible scenarios once EFSA has completed it’s evaluation of the further dossiers submitted to it to support the permanent exemption of certain derived products. The first is that all the derived products that are provisionally exempt under the 2005 Regulations will gain permanent exemption. In this case, it might be possible to fast track the implementation of national legislation once the European legislation is published, as this would not result in any changes to the current provisions.
We would welcome your views on a second scenario that would allow some derived products provisionally exempt under the 2005 Regulations, to gain permanent exemption. In this case, although national legislation could be fast tracked, with a shortened public consultation period, there will potentially be impacts on industry as some derived products that currently do not have to be declared with reference to the source allergenic food, will need to have that declaration.
We would welcome your views on: the minimum length of any implementation period that would be needed. It would be helpful if comments on this issue could be received as soon as possible as we aim to have exploratory discussions with the European Commission in July.
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.
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