FSA Consultation Letter, 18 May 2011
A copy of the consultation document and draft Regulations are available on this site. See: Extraction Solvents Consultation
To provide stakeholders with an opportunity to comment on the provisions of the draft Extraction Solvents in Food (England) (Amendment) Regulations 2011, which would implement Commission Directive 2010/59/EU in England. Responses are requested by: 17 June 2011
Who will this consultation be of most interest to?
Manufacturers of extraction solvents, food and flavourings manufacturers using extraction solvents and enforcement authorities.
What is the subject of this consultation?
National regulations relating to England to implement European Commission Directive 2010/59/EU. This directive permits the use of a newly approved extraction solvent dimethyl ether in the preparation of defatted animal protein products at a maximum limit of 0.009 mg/kg and clarifies the limits for two existing extraction solvents in the preparation of flavourings.
What is the purpose of this consultation?
To provide stakeholders with an opportunity to comment on the provisions of the draft Extraction Solvents in Food (England) (Amendment) Regulations 2011, which would implement Commission Directive 2010/59/EU in England.
The European Food Safety Authority (EFSA) evaluated the safety of dimethyl ether as an extraction solvent to remove fat from animal protein raw materials. In its opinion (see link below) published in early 2009, EFSA concluded that there is no safety concern provided that the maximum residual limit of dimethyl ether in the defatted protein product does not exceed 0.009 mg/kg. An amendment to the European extraction solvents legislation was considered necessary to reflect EFSA's opinion. In addition, the opportunity has been taken to amend the legislation to clarify limits for the approved extraction solvents methanol and propan-2-ol for use in the preparation of flavourings from natural flavouring materials. The original extraction solvents directive does include maximum residue limits for those two solvents in food ingredients themselves and industry was concerned that, if those limits were held to apply to extracted flavourings themselves, it would not be able to comply. Hence the limits are being clarified by inclusion of more generous maximum residue limits in food where either of the solvents has been used in the preparation of flavourings.
The European Commission Directive
In January 2010, the European Commission issued a proposal to make amendments to Directive 2009/32/EC (extraction solvents used in the production of foodstuffs and food ingredients) in order to (a) permit an additional extraction solvent (dimethyl ether) on which EFSA had given a favourable opinion to remove fat from animal protein raw materials and (b) clarify the levels at which levels methanol and propan-2-ol could be used in the preparation of flavourings from natural flavouring materials. The general residue limit of 10 mg/kg for methanol and propan-2-ol in Directive 2009/32/EC is too strict in terms of industry’s ability to comply if applied directly to flavourings.
The Commission's proposal was adopted by qualified majority in the EU Standing Committee on the Food Chain and Animal Health (SCOFCAH) in May 2010 and was published in the Official Journal of the EU as Commission Directive 2010/59/EU on 27 August 2010.
Purpose of Consultation:
The purpose of this consultation is to provide stakeholders with an opportunity to comment on the draft Extraction Solvents in Food (England) (Amendment) Regulations 2011, which would implement the Directive in England. Separate consultations will be carried out in Scotland, Wales and Northern Ireland on draft regulations relating to those parts of the UK.
The draft Extraction Solvents in Food (England) (Amendment) Regulations 2011 are attached at Annexe B. These regulations would implement the Commission Directive by making amendments to the Extraction Solvents in Food Regulations 1993 (as amended) (S.I. 1993/1658), in accordance with the Government’s Guiding Principles for EU Legislation. We propose to implement it by the Commission’s deadline of 15 September 2011.
FSA consulted industry during EU negotiations on the Directive. Industry said that there would be only a negligible impact and raised no objections to the proposed changes to the extraction solvents legislation. Permitting the use of the new extraction solvent and clarifying the levels at which levels methanol and propan-2-ol can be used in the preparation of flavour from natural flavouring materials will have a negligible incremental impact on industry.
As there will be only negligible incremental impact on UK industry arising from the implementation of the directive, the FSA has not prepared an impact assessment (IA) on this occasion. Should this consultation bring to light any new impacts, the FSA will reconsider the need for an IA.
Given the minimal impact and the intention to implement the Directive by the Commission’s deadline of 15 September 2011, 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 impact (if any) would the key proposals have on your current formulation process costs? The FSA welcomes responses, preferably with an evidence backing, to inform any estimated costings.
3.If applicable, how much is this likely to cost/save, broken down by activity?
4.Would industry be required to familiarise itself with the key proposals? If applicable, how much time would a business need to invest to read and familiarise itself with this regulation and disseminate to key staff?
5.Would you be able to comment and provide evidence on any additional costs and benefits (if any) associated with the key proposals?
6.Do you think that the regulations, if enacted as drafted, would achieve these aims of the Commission directive?
Other relevant documents:
Commission Directive 2010/59/EU of 26 August 2010 amending European Parliament and Council Directive 2009/32/EC on the approximation of the laws of the member states on extraction solvents used in the production of foodstuffs and food ingredients.
Responses are required by close Friday 17 June 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).