Plastic Materials and Articles in Contact with Food (Lid Gaskets) (Scotland) Regulations 2007
Friday 29 June 2007
The proposed draft Plastic Materials and Articles in Contact with Food (Lid Gaskets) (Scotland) Regulations 2007 will make provision for the enforcement authorities in Scotland to enforce the requirements of Commission Regulation (EC) No. 372/2007 that lays down transitional migration limits for plasticisers in gaskets in lids intended to come into contact with foods.
All comments and views should be sent to:
Food Standards Agency Scotland
Contaminants, Hygiene, Additives & Shellfish Branch
6th Floor, St Magnus House
25 Guild Street
Aberdeen AB11 6NJ
Tel: 01224 285170
Fax: 01224 285168
Responses are requested by: 10 August 2007
The key proposals provide for:
- the enforcement of Regulation (EC) No. 372/2007 by devolving responsibility for the enforcement in Scotland to the local enforcement authorities
- offences under the regulation and for defences against conviction for committing an offence in particular circumstances
- penalties that the Courts may apply upon conviction for an offence
A new directly applicable time-limited European Regulation (EC) No. 372/2007 on materials and articles intended to come into contact with food came into force on 22 April 2007. It lays down transitional migration limits for plasticisers in gaskets in lids intended to come into contact with food. Without the proposed Scottish Regulations that are the subject of this consultation, the normal offences, penalties and devolved powers of enforcement will not be in place. Thus, this consultation is time-limited for six weeks, as opposed to the normal 12 weeks, because of the short-term nature of the proposed Regulations that will apply. In the longer term the transposition of Commission Directive 2007/19/EC will properly put these measures in place. These proposed Scottish Regulations will cease to have effect when the time limit on the European Regulation expires.
We would welcome your comments on the proposed draft Plastic Materials and Articles in Contact with Food (Lid Gaskets) (Scotland) Regulations 2007, included in the attached document. The proposed Regulations make provision, in relation to the EC Regulation, for:
- enforcement in Scotland by the local enforcement authorities as prescribed by the Food Safety Act 1990
- offences where alleged breaches arise
- defences that might apply in particular circumstances in the event of offences being alleged
- penalties that will apply upon conviction for an offence
The European Regulation was published in the Official Journal (OJ) of the European Union (EU) on 3 April 2007 (OJ L92 3.4.2007 p.9-12). It came into force on 22 April 2007 and is directly applicable throughout the EU, and shall apply until 30 June 2008. A copy of the European Regulation is included in the attached document and is also available to download free of charge from the EU website.
The Food Standards Agency in England, Wales and Northern Ireland will each consult on parallel but separate Regulations
Gaskets in lids intended to come into contact with food fall under the scope of the plastics Directive 2002/72/EC, as amended. However, the Directive applies to materials and articles, and parts thereof, which consist exclusively of plastics or are composed of two or more layers consisting exclusively of plastics. Gaskets in metal lids could alternatively be regarded as a plastic part of a material or article and thus covered by Directive 2002/72/EC or as a plastic coating on a metal substrate, and hence, not covered by that Directive. Consequently, there are separate rules across Member States that may pose a barrier to trade. As such, it has been necessary to clarify the position regarding gaskets in lids and fix transitional specific migration limits (SMLs). These SMLs will apply to the sum of a number of plasticisers used in gaskets in lids coming into contact with fatty foods and permit the free circulation of those products affected. The lids and foods that pose a significant risk will be immediately excluded from the market. The European Regulation also provides industry with sufficient time to finalise the development of gaskets that are compliant with the SML laid down in Directive 2002/72/EC, as amended by Directive 2007/19/EC.
The plasticisers with the transitional SML are:
- Epoxidised Soybean oil (ESBO)
- Acetylated mono- and diglycerides of fatty acids
- Polyester of adipic acid with glycerol or pentaerthritol, esters and even numbered, unbranched C12- C22 fatty acids
- Tri-n-butyl citrate
- Glycerol monolaurate diacetate and 12-(Acetoxy) stearic acid, 2,3-bis(acetoxy)-propyl ester
- Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropylene-glycol with adipic acid, also end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol
During the course of European negotiations all organisations on the Agency’s database of contacts with an interest in the development of policy, issues and legislation on food contact materials were consulted on the initial development of proposals in early 2005. Subsequently an informal consultation took place in October 2005, when those proposals were last amended. The proposal was also discussed less formally, during regular meetings with particular stakeholders groups likely to be directly affected by the requirements of the European Regulation. Comments received during and after informal consultations indicated that those businesses likely to be affected welcomed the introduction of transitional migration limits.
Enforcement requirements for EC Regulation 372/2007
The purpose of the proposed SI, and the subject of this consultation, is to provide for the enforcement of the European Regulation in Scotland. They also provide that any person who fails to comply with the requirements of Regulation 372/2007 is liable, if convicted of an offence on indictment under Section 4(1)(a) under these Regulations, to a term of imprisonment not exceeding two years or to a fine or both; on summary conviction they are liable to a term of imprisonment not exceeding six months or to a fine not exceeding the statutory maximum or both.
Proposed timetable for the Scotland amendment Regulations – dates and introduction
- public consultation starts: 29 June 2007
- public consultation ends: 10 August 2007
- target date for making the regulations: September 2007
- target date for coming into force of the regulations: October 2007
Submitting comments on the proposed regulations for Scotland
The informal consultation carried out in October 2005 did not raise any pertinent issues about the cost implications in relation to the European Regulation from enforcement authorities. However, we welcome their comments on the proposed regulations, in so far as they relate to the provisions for enforcement, offences, defences and penalties. We would also welcome comments on any likely costs that will be incurred in implementing the enforcement proposals. Although the costs arising from the need to comply with the European Regulation are not strictly part of the impact assessment here, it is always helpful 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 European Regulation, they should be shown under separate headings from those attributable to the Regulation for Scotland that is the subject of this consultation. If these costs are indivisible or unquantifiable, it would be helpful to have this made clear.
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.
Publication of personal data and confidentiality of responses
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.
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Publication of response summary
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