FSA Consultation Letter, 26 February 2010

PACKAGING – Proposed Materials and Articles in Contact with Food (England) Regulations 2010

A copy of the consultation document is available on this site. See: Proposed Materials and Articles in Contact with Food (England) Regulations 2010

Responses are requested by: 24 May 2010

Audience

Who will this consultation be of most interest to?

Enforcement authorities, port health authorities and trading standards officers involved in the enforcement of the law governing these materials and articles. Businesses that manufacture, use and import active and intelligent materials and articles intended to come into contact with food will want to be aware of them and the associated guidance.

What is the subject of this consultation?

Provisions for the enforcement in England of the requirements of Commission Regulation (EC) No. 450/2009 on active and intelligent materials and articles intended to come into contact with foods and the associated guidance. New offences for breaching the regulation, some defences against prosecution and penalties for the Courts to apply.

What is the purpose of this consultation?

To seek comments from enforcement authorities, port health authorities and businesses on the proposed regulations and the associated guidance, to make businesses aware of the requirements and to provide opportunity for interested parties to comment on the proposals and the draft guidance.

Consultation details

The Food Standards Agency welcomes your comments on the proposed Materials and Articles in Contact with Food (England) Regulations 2010, which can be found at Annex B via the link towards the end of this page. The proposed Regulations will provide for the enforcement of certain provisions of Commission Regulation (EC) No. 450/2009 on active and intelligent materials and articles intended to come into contact with foods ('the AIM Regulation'), by designating the appropriate enforcement authorities in England and by attaching penalty provisions to the substantive requirements of the AIM Regulation. Comments are also requested on the Impact Assessment, which can be found at Annex C via the link towards the end of this page. In the latter case, we would particularly welcome comments on any cost implications that may arise from this proposal.

The AIM Regulation was published in the Official Journal (OJ) of the European Union (EU) on 30 May 2009 (Ref OJ, 30.05.2009, L135 pg 3-11), and came into force on 20 June 2009 and is directly applicable throughout the EU. Copies of the AIM Regulation can be freely accessed and downloaded from the following European Commission via the link below.

The Food Standards Agency in Scotland, Wales and Northern Ireland will each consult on parallel but separate Regulations that will apply in their territories.

Comments are also requested on the draft guidance notes attached at Annex E (see paragraph 11), which accompany the proposed Regulations; when submitting comments, please indicate whether you are commenting on the guidance notes or the draft Regulations.

The general principles on all food contact materials and articles intended to come into contact with foodstuffs are established in Regulation (EC) No. 1935/20041 ('the framework Regulation'). This lays down the framework for the regulation of all materials and articles intended to come into contact with food, including those classed as 'active' or 'intelligent'. The AIM Regulation is a specific measure within the meaning of Article 5(1)(b) of the framework Regulation. This establishes specific rules for active and intelligent materials and articles to be applied in addition to the general requirements established in the framework Regulation for their safe use.

Details of the AIM Regulation are:

The AIM Regulation puts in place safety requirements that have to be met by businesses seeking to place on the market active and intelligent food packaging systems that give the foods they contain longer shelf life, enhanced qualities and that give businesses and consumers better information regarding the condition of the packaged food. The requirements prevent businesses misleading consumers about the product they are buying. They also lay down the procedure that manufacturers of such packaging systems must follow to have their product authorised at European Union level and provide for dates by which goods must comply with these regulations and when goods will be in breach of them.

The AIM Regulation also requires that only substances in the Community list of authorised substances may be used in components of active and intelligent materials and articles. In order for substances to be included in the Community list, specific conditions must be met and these have to satisfy the requirements of Article 3 and, where they apply, Article 4 of the framework Regulation for their intended use.

The Community list will be established in agreement with the member states, with detail on the deadlines by which events pertaining to the list must be completed and the procedures for drawing up the list. The list will be drawn up in accordance with the applications made under Articles 9 of the framework Regulation and adopted by the Commission under the procedure set out in Articles 10 and 11 of that Regulation.

Applications for the inclusion of substances in the EU list must be submitted within 18 months of the publication of the European Food Safety Authority (EFSA) guidelines for safety assessment of substances – that is to say by 31 May 2011. The EFSA guidelines were issued on 30 November 2009 and are available on the Commission website via the link below.

The AIM Regulation puts in place a transitional period whereby active and intelligent materials and articles that are labelled in accordance with the framework Regulation and placed on the market prior to 19 December 2009 are permitted to be sold until stocks are exhausted. Furthermore, until the date of application of the EU list, released active substances are to be authorised and used in accordance with the relevant Community provisions applicable to food (i.e. legislation on food additives and enzymes), and must comply with the provisions of the framework Regulation and its implementing measures. A released active substance shall be considered as an ingredient within the meaning of Directive 2000/13/EC and subject to the provisions of that Directive.

More detailed information on the requirements of the AIM Regulation can be found in the Impact Assessment.

1 OJ Ref L338, 13.11.2004

Proposals:

The proposed Materials and Articles in Contact with Food (England) Regulations 2010 will newly provide for the enforcement in England of those provisions contained in the AIM Regulation that were not initially enforced by the Materials and Articles in Contact with Food (England) (Amendment) Regulations 2009. They also remake provisions of the 2007 Regulations, as amended, that remain extant.

The Agency believes that the adoption of these proposals provides for the continuation of consumer protection through enforcement of rules that protect consumers against dangerous levels food contamination by the adventitious migration into food of chemicals whose ingestion would carry serious long term and unacceptable risk to consumer health, in particular amongst vulnerable people. The introduction of harmonised statutory controls would reduce the potential for uncertainty or dispute in relation to safe levels of substances migrating from active or intelligent materials and articles.

An earlier consultation was carried out in August 2009 on the enforcement of a number of provisions in the AIM Regulation. Those provisions related to particular labelling and declaration requirements for goods placed on the market. Article 14 of the AIM Regulation required that Articles 4(f), 11(1) and (2), 12 and 13 shall apply from 19 December 2009. These specifically concerned the labelling of parts of the packaging that could be wrongly taken by some consumers to be edible, the written declaration of legal compliance to accompany active and intelligent materials and articles prior to retail sale, and the production, to enforcement authorities on request, of supporting documentation to substantiate the declaration of compliance. These provisions had to be in place by 19 December to ensure that enforcement authorities had the necessary powers to act under the AIM Regulation at the time they came into force.

The Materials and Articles in Contact with Food (England) (Amendment) Regulations 20092 provided for the enforcement of the above provisions in England.

Key proposal(s):

• To provide for the enforcement of the remaining provisions contained in the AIM Regulation, by designating local authorities and port health authorities as having responsibility for the enforcement of these provisions in England.
• To provide for offences under the Regulation and for defences against an alleged offence in particular circumstances.
• To specify the penalties that the Courts may impose upon conviction for an offence.
• To revoke The Materials and Articles in Contact with Food (England) Regulations 2007 and its 2009 amendment Regulations and remake, with necessary amendments, taking into account the remaining enforcement provisions of the AIM Regulation.
• To issue guidance to help enforcement authorities

2 Statutory Instrument No. 2009/2938

Consultation Process:

During the course of negotiations with the European Commission, officials of the Agency have frequently conveyed information to interested organisations; including industry, research institutes, consumer groups, enforcement authorities and any other parties with an interest and policy issues related to food contact materials. Earlier stages in the development of these proposals have been subject to two previous consultations, one in 2006 and again in 2008, when these proposals were last amended. These previous consultations did not raise any adverse comments from stakeholders.

The informal consultations carried out in 2006 and 2008 did not raise any pertinent issues about cost the implications in relation to the AIM Regulation from enforcement authorities or businesses. There were however, several comments on points of detail from the 2008 consultation that were noted and, where they did not affect overall UK negotiating lines, were raised in discussions with the Commission and other EU member states and, in some cases small changes to the text of the AIM Regulation resulted.

Questions asked in this consultation:

• Is our assumption that there are no new or additional costs associated with the proposed Regulations an accurate assessment with regard to enforcement authorities, other than reading and familiarising with the proposed Regulations? If you disagree with this assessment, please provide evidence to support your views.
• Is our assumption that there are no new or additional costs associated with the proposed Regulations statement an accurate assessment for businesses, other than reading and familiarising with the proposed Regulations? If you disagree with this assessment, please provide evidence to support your view.
• Is our assumption that there are no new or additional administrative burdens associated with the proposed Regulations a reasonable one for both enforcement authorities and businesses? If you disagree with this assessment, please provide evidence to support you views.
• If you believe that the proposed Regulations do introduce any new administrative costs, over and above what a business would do in the normal course of their commercial activity, please provide evidence to support your views.
• We would now welcome comments on the proposed Regulations in so far as they relate to the remaining provisions for enforcement, defences and penalties. We would also welcome comments on any costs likely to be incurred in implementing the enforcement proposals. Although costs arising from the need to comply with the AIM Regulation are not strictly part of the consultation, any that can be provided will help us to provide a full picture of any burdens (particularly administrative burdens) placed upon those affected by the proposals. Where the costs for compliance relate to the AIM Regulation itself, they should be shown under separate headings from those attributable to the enforcement issues dealt with the proposed Regulations for England, which are the subject of this consultation. If these costs are indivisible or unquantifiable, this should be made clear.
• Any other comments you are able to provide in relation to the proposed Regulations would be helpful. We would be particularly keen to from small businesses on any likely impact of the Regulations and would encourage them to comment on all aspects of the proposal and its intended effect.
• We would also welcome comments on the industry guidance (attached at Annex E). Although the guidance is primarily aimed at enforcement authorities on new powers and responsibilities, it may also however, be of use to others with an interest in the legislation. 8. 9. 10.

In particular we would welcome your views on:

• the content and form of the guidance
• the layout of the guidance
• the clarity of the guidance
• whether any more simplified guidance is needed for small businesses or for particular business sectors and, if so, what form you think that guidance should take

Industry guidance on the draft Materials and Articles in Contact with Food (England) Regulations 2010

These guidance notes have been produced to explain clearly the legal requirements of The Materials and Articles in Contact with Food (England) Regulations 2010. Every effort has been made to ensure that these guidance notes are as helpful as possible. They cannot cover every situation and you may need to consider the relevant legislation itself to see how it applies in your circumstances. If you do follow the guidance notes they will help you to comply with the law. Businesses with specific queries may wish to seek the advice of their local enforcement agency, which will usually be the trading standards/environmental health department of the local authority.

Responses:

Responses are required by close of Monday 24 May.