FSA Consultation Letter, 14 June 2007
For a copy of the FSA consultation document, see: Allergen Amendment Consultation
The Agency seeks views of the draft Food Labelling (Declaration of Allergens) (England) 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. Responses are requested by: 4 September 2007
Food Labelling (Declaration of Allergens) (England) Regulations
The Food Labelling (Amendment) (England) (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 pre-packed 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 (EFSA) 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) (England) Regulations will implement Commission Directive 2006/142/EC, of 22 December 2006, amending Annex IIIa of Directive 2000/13/EC, by adding lupin and molluscs to the list of allergens in Schedule AA1.
Separate but parallel legislation will be made in respect of England , Scotland , Wales and Northern Ireland .
Partial regulatory impact assessment
The options are set out in the attached Partial Regulatory Impact Assessment (‘RIA') in respect of an amendment to the Food Labelling Regulations 1996 (as amended) (‘FLR') (in so far as they apply in relation to England ). In England , these regulations implement in England Commission Directive 2006/142/EC, which amends Annex IIIa of Directive 2000/13/EC of the European Parliament and of the Council listing the ingredients which must under all circumstances appear on the labelling of foodstuffs. Two new ingredients are added to that list, namely molluscs and lupin.
The Agency has also taken this opportunity to revise and merge the separate guidance notes on the Food Labelling (Amendment) (No. 2) Regulations 2004 and the Food Labelling (Amendment) (No. 2) Regulations 2005 (as amended). The draft of the new guidance notes is included in the accompanying document. 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 product sare 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 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.
Directives 2005/26/EC and 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 enacted into national legislation by the Food Labelling (Amendment) ( England ) (No. 2) Regulations 2005 in England and parallel regulations in Scotland , Northern Ireland and Wales .
There are a number of possible scenarios once EFSA has completed its 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. Your views on this are sought.
A second scenario is that some, but not all, the derived products that are provisionally exempt under the 2005 Regulations 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 are therefore seeking views on the minimum length of any implementation period that 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.