FSA Consultation Letter, 25 March 2004
Proposed Regulations implementing two EC directives on materials and articles intended to come into contact with foodstuffs. Responses are requested by: 17 June 2004
This consultation invites comments on proposals to transpose two European Commission
Directives into English law. Comments are also invited on an initial assessment
of the impact of the proposed Regulations. The proposed Regulations and the
Regulatory Impact Assessment are attached below. The Food Standards Agency in
Scotland, Wales and Northern Ireland will each consult on parallel but separate
The Regulations being proposed, The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2004 would implement two Directives on materials and articles coming into contact with food. These are Directive 2004/13/EC, on the use of certain epoxy derivatives, and Directive 2004/1/EC, on the suspension of the use of azodicarbonamide as a blowing agent. They were adopted in January 2004 and published in the Official Journal (OJ) of the European Communities in January (OJ references L 7/45 (Directive 2004/1/EC of 13th January 2004) and L 27/46 (Directive 2004/13/EC of 30 January 2004).
Reasons for changing the rules
The use of food contact plastics in Great Britain is controlled by The Plastic Materials and Articles in Contact with Food Regulations 1998 (SI 1998 No. 1376), as amended (by SIs 2000 No. 3162, 2002 No 2364 and 2002 No. 2008). In our Regulations, SI 2002 No. 2364 amends the 1998 Regulations in relation to the provisions for BADGE, BFDGE and NOGE and their derivatives. This current proposed amendment would extend the provisional authorisation for the use of BADGE, for a further 12 Months to allow for more scientific data to be produced.
The provision for azodicarbonamide occurs in SI 2000 No. 3162, where Regulation 11 brings in Schedule 2 amendments and item 27a makes the addition of azodicarobonamide to Schedule 2 in the 1998 Regulations. The current amending Regulation would prohibit the use of azodicarbonamide as a blowing agent from 2 August 2005.
Commission Directive 2004/13/EC, on the use of certain epoxy derivatives, is relatively straightforward and sets out to do two things. Article 1 extends the provisional authorisation of the use of BADGE in the manufacture of food contact plastics, coatings and adhesives for a further 12 months until 31 December 2005. Article 2 seeks to clarify how the date of filling may be applied to containers that have a coating which contains BADGE, BFDGE or NOGE.
It makes it clear that the containers must comply with the requirement that only those containers filled or brought into contact with food before 1 March 2003 may be placed on the market and only then providing they are marked with the date on which they were filled. The proposal also provides that a coded date may be used, an indication as the directive calls it, and that the competent authorities and enforcement officers shall have the actual date made available to them on request.
Directive 2004/1/EC as regards to the suspension of the use of azodicarbonamide as a blowing agent is also straightforward. The proposal amends the entry on azodicarbonamide, which was permitted for use as a blowing agent in food contact plastics without restrictions, and now prohibits its use as from 2 August 2005. In addition Article 2(2) second paragraph provides that materials and articles filled before 2 August 2005 may continue to be placed on the market provided the date of filling appears on them. The Directive repeats the provision on date marking outlined above in the requirement in Directive 2004/13/EC.
It is proposed to implement the requirements of both these Directives in one set of Regulations. The requirements of each Directive have to be in force at different times and this is reflected in the proposed Regulations. Directive 2004/13/EC has to be in force by 29th January 2005 and Directive 2004/1/EC has to be in force and fully implemented by 2nd August 2005. Although the proposal will put the Regulations in place by 29th January 2005 the two parts will not take effect until their proper time. This will enable the necessary technical changes to be made to the existing Regulations on plastic materials and articles.
Who will be affected by the new Regulations?
Within the European Union consumers should benefit from these Regulations. The EU measures should have equal effect across the European Union, ensuring that UK consumers will have the same health protection from the excessive consumption of substances dealt with in these proposals, as consumers in the rest of the EU. The primary business sectors affected by these proposals will be manufacturers of food contact plastics, food processors and, more specifically those that employ azodicarbonamide as a blowing agent. Local enforcement Authoritys will benefit from the greater clarity with which their rights of access to information are spelled out.
Proposed timetable for the New Regulations
Important dates in the introduction of the New Regulations are:
Submitting comments on the draft Regulations
We would welcome your comments on the proposed Regulations and the Regulatory Impact Assessment. It is envisaged that the proposal for directive 2004/13/EC is likely to have little or no cost impact. However, there is a possibility of a likely cost impact to industry of £300-500K per annum on the proposal for directive 2004/1/EC. This is likely to arise from the need to find an alternative substance to replace azodicarbonamide. We would welcome comments on likely costs of implementing both Directives and:
To see copies of the related documents on the FSA web site, go to: http://www.food.gov.uk/foodindustry/Consultations/completed_consultations/compconsulteng/192273