Draft Plastic Materials and Articles in Contact with Food (Scotland) Regulations 2008

The key proposals are to:

• implement European Commission (EC) Directive 2007/19/EC in Scottish law
• revoke the Plastic Materials and Articles in Contact with Food (Scotland) (No.2) Regulations 2006 and remake them with necessary amendments

We would welcome your comments on the proposed Plastic Materials and Articles in Contact with Food (Scotland) Regulations 2008, included in the document at the link below. The proposed regulations will implement the requirements of Commission Directive 2007/19/EC on plastic materials and articles intended to come into contact with food. Comments are also requested on the Impact Assessment included in the accompanying document. In the latter case, the FSA particularly welcome comment on any cost implications that may arise from this proposal. The EC Directive was published in the Official Journal of the European Communities on 30 March 2007 (OJ Ref. L97, 12.4.2007 p50-69). This directive is included in the accompanying document. The Food Standards Agency in England, Wales and Northern Ireland will each consult on parallel but separate regulations.

Reasons for changing the rules
Harmonised European rules on food contact plastics are laid down by Commission Directive 2002/72/EC. These rules are routinely amended as technical and scientific knowledge develops and as the harmonisation of the rules across the European Union (EU) is extended. The Plastic Materials and Articles in Contact with Food (Scotland) (No.2) Regulations 2006 implement the provisions of Directive 2002/72/EC in Scotland.

Commission Directive 2007/19/EC relating to plastic materials and articles intended to come into contact with food
Commission Directive 2007/19/EC amends Commission Directive 2002/72/EC on plastic materials and articles intended to come into contact with food by making routine amendments to the European Community list of authorised monomers and other starting substances in Annex ll to the 2002 directive and to the incomplete list of additives in Annexe lll to that Directive. These amendments include new substances and amend the entries for existing ones following risk assessments published by the European Food Safety Authority (EFSA).

In particular, Directive 2007/19/EC provides new limitations on the use of and migration limits for certain plasticisers, including epoxydised soybean oil (ESBO) and some phthalates. It also amends Council Directive 85/572/EEC by introducing a fat-reducing factor (FRF) which can provide a better estimation of consumer exposure to substances migrating into fatty foods

The amending directive provides clarification for the term 'plastic multi-layer'; it brings such materials firmly within the scope of these rules and distinguishes them from the 'plastic functional barrier'. There are provisions for the use of plastic functional barriers to help in reducing the migration of a substance below its Specific Migration Limit (SML). The ambiguity surrounding what constitutes metal gaskets in lids has now been clarified by this amending directive. Metal gaskets in lids now fall under the scope of Directive 2002/72/EC.

The amending directive also provides time for manufacturers to apply for the evaluation of specific additives which are not currently included in the lists of authorised substances. The positive list of authorised additives that will be adopted in the future for plastic materials and articles will not apply to the manufacture of gasket lids. The transitional use of other additives for the manufacture of gasket lids is the subject of Commission Regulation (EC) No 372/2007. The Scottish regulations that provide for the enforcement of Regulation 372/2007 will come into force on 29 October 2007. Similar legislation will apply in England, Wales and Northern Ireland.

The suspension on the use of azodicarbonamide as a blowing agent has now been revoked by the directive and replaced by an outright ban. Also, the new directive requires detailed information on compliance declarations and that certificates should attest to the restrictions or specification applicable to the substances used in the manufacture of food contact plastic materials and articles. Other information, such as the date of declaration, identity of the materials, articles or substances intended for manufacturing, and the type or types of food which the material is intended to be put in contact with – is also required.

The amending directive also amends Council Directive 85/572/EEC, which lays down the list of simulants to be used for testing migration of constituents of plastic materials and articles in contact with foodstuffs, by introducing an FRF that can provide a better estimation of consumer exposure to substances migrating into fatty foods.

Implementation
It is proposed that the requirements of the directive be implemented into one complete set of regulations, namely the Plastic Materials and Articles in Contact with Food (Scotland) Regulations 2008. These Regulations have to be in force by 1 May 2008.

Who will be affected by the new regulations
Within the EU, consumers should benefit from the safer food contact plastic products that result from compliance with the proposed regulations. The measure should have equal effect across the EU, ensuring that UK consumers have the same health protection as consumers in the rest of the EU from any health effects that might arise from excessive consumption of the substances controlled by these proposals. The primary business sectors affected by these proposals will be those that manufacturer and/or import plastic food packaging and other plastic materials and articles intended for food contact, including those companies that specifically manufacture gaskets for use in lids which use substances with restrictions laid down in the directive. Local enforcement authorities will benefit from the greater clarity of the rules and from having their rights of access to information spelled out. Charities and voluntary organisations are unaffected by this proposal.

Proposed timetable for the new regulations
Important dates in the introduction of the new regulations are:

• public consultation starts 7 November 2007 (12 weeks)
• public consultation ends 31 January 2008
• target date for making regulations 1 May 2008

Submitting comments on the draft regulations
We would welcome your comments on the proposed regulations in so far as they relate to Scotland. In particular, the proposed regulations introduce the use of 'ambulatory' references by virtue of the Legislative and Regulatory Reform Act 2006, which allows the use of ambulatory references, where necessary. The ambulatory references in the proposed Plastic Materials and Articles in Contact with Food (Scotland) Regulations 2008 are to the Annexes to Commission Directive 2002/72/EC, which contain lists of chemical compounds and technical specifications that are subject to regular updating and amendment by the EC. The use of ambulatory references will avoid the need to introduce a new Statutory Instrument each time these Annexes or the Commission Directive is updated. We would welcome your comments on whether you agree with this approach.

We would also welcome comments on the likely cost of implementing Directive 2007/19/EC and particularly those that are attributable to the regulations for Scotland.

Please also comment on:

• how the proposed regulations implement this directive
• any other issue raised by the proposed regulations

Submitting comments on the Impact Assessment (IA)
We would also welcome your comments on the Impact Assessment, particularly from those representing businesses who may be affected.

Options – two options are being considered – we would welcome comments on the assertions that option 2 has the desired effect in support of the proposal. If you disagree with this assessment and/or favour option 1, please provide evidence to support your view.

Evidence base – analysis of options. We have estimated that any possible cost to businesses and enforcement authorities on the proposal to implement the provisions of Directive 2007/19/EC in Scotland likely to be from reading and familiarisation with the new regulations. These costs are based on the time it would take businesses to read and familiarise themselves with the regulations. If you disagree with our assessment contained the summary sheets please provide appropriate evidence on financial costs associated with the EC directive and/or the proposed Scottish regulations to support your view.

Policy and administration costs – We would welcome comments on our view that any new administrative action is likely to be minimal. We would also welcome your comments and evidence to support your view, if you believe that the proposed regulations introduce any new administrative costs, over and above what a business would do commercially.

Costs and benefits – sectors and groups affected – Comments are required on the number of companies that are likely to be affected by this provision and on any costs or benefits that can be identified. For example, this could be savings accruing to enforcement authorities, the Courts and those companies responsible for compliance (see summary analysis and evidence page of the Impact Assessment) or the number of hours possibly saved/reduced (and at what level of operator) as a result of having a set of regulations that have been simplified.

Competition assessment – We would welcome any comments on our view that the proposals are unlikely to significantly affect competition. If you disagree with our assessment, please provide evidence to support your view. We do not currently have sufficient data to carry out a detailed analysis.

Other comments – Any other comments you able to provide either in relation to the Impact Assessment or the proposed Scottish regulations would be helpful. We would be particularly keen to hear from small businesses on any likely impact of the new regulations and would encourage them to comment on all aspects of the proposal and its intended effect.

Specific questions for this consultation
Does any company have more than a 10%, 20% or 50% share of the market affected by these proposals or the EC Directive?

Would the cost of these proposals or the EC Directive affect some businesses substantially more than others?

Are these proposals or the EC Directive likely to affect the market structure, changing the number or size of the businesses?

Would these proposals or the EC Directive lead to set-up costs for new or potential firms that existing firms do not have to meet?

Would these proposals or the EC Directive lead to higher on-going costs for new or potential businesses compared with existing firms?

Is the sector characterised by rapid technological change?

Would these proposals or the EC Directive restrict the ability of businesses to choose the price, quality, range or location of their products?

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.

Consultation feedback questionnaire (Word)

Consultation feedback questionnaire (pdf)

In accordance with the FSA principle of openness our Information Centre at Aviation House will hold a copy of the completed consultation. The FSA will publish a summary of responses, which may include personal data, such as your full name. Disclosure of any other personal data would be made only upon request for the full consultation responses. If you do not want this information to be released, please complete and return the Publication of Personal Data Form. Return of this form does not mean that we will treat your response to the consultation as confidential, just your personal data.

Data protection form (Word)

Data protection form (pdf)

Within three months of a consultation ending we aim to publish a summary of responses received and provide a link to it from this page.

If, after three months, the summary is still not showing, please contact the person who was responsible for the original consultation. Alternatively, you can contact the FSA Consultation Co-ordinator by email: consultationcoordinator@foodstandards.gsi.gov.uk