FSA Consultation Letter, 14 May 2007
For a copy of the FSA consultation document, see: Material and Articles Proposals
The proposed draft Materials and Articles in Contact with Food ( England ) Regulations 2007 will make provision for authorities in England to enforce the provisions of Commission Regulation (EC) No. 2023/2006, on good manufacturing practice (the ‘GMP Regulation'). This GMP Regulation applies to all materials and articles intended to come into contact with food. Responses are requested by: 3 August 2007.
The key proposals are:
The GMP Regulation was published in the Official Journal (OJ) of the European Union (EU) on 29 December 2006 (OJ L384 29.12.2006 p.75-78). It came into force on 18 January 2007 and is directly applicable throughout the EU, but does not apply until 1 August 2008. This delay provides time for those affected by the Regulation to put measures in place to comply with its requirements. A copy of the GMP Regulation is available from EU website.
The Food Standards Agency in Scotland , Wales and Northern Ireland will each consult on parallel but separate Regulations that will apply in their territories.
Article 3 of the Framework Regulation, (EC) No. 1935/2004, lays down the general requirement that all materials and articles shall be manufactured in compliance with good manufacturing practice. However, the term ‘good manufacturing practice' is not further defined in that Regulation. The new GMP Regulation lays down the detailed principles to be incorporated into GMP protocols to ensure uniformity and conformity amongst member states across the EU. The GMP Regulation defines GMP to ensure that materials and articles are consistently produced and controlled to conform with the rules applicable to them and with quality standards appropriate to their intended use.
The GMP Regulation will apply to all sectors and to all stages of manufacture, processing and distribution of materials and articles, but excluding the production of starting substances. The detailed rules set out in the current annex to the EC Regulation shall apply to the application of printing inks to non-food contact surfaces of materials and articles in contact with food. Other annexes are likely to be added later dealing with other specific GMP issues.
Enforcement requirements for EC Regulation 2023/2006
The proposed regulations provide for Food Authorities, as defined by the Food Safety Act 1990 to provide for the enforcement in England and have done so in respect of the Framework Regulation 1935/2004, as sanctioned by The Materials and Articles in Contact with Food ( England ) Regulations 2005. Thus, the proposed English regulations on which we are consulting merely provide the means by which this role can continue under the GMP Regulation.
They also provide that any person who fails to comply with the requirements of Article 4 of the GMP Regulation is guilty of an offence under these and other regulations dealing with materials and articles in contact with food is liable on conviction on indictment to a fine or imprisonment for a term not exceeding two years or both; on summary conviction to a term of imprisonment not exceeding 3 months or a fine not exceeding level 5 on the standard scale or both.
Proposed timetable for the England amendment Regulations – dates and introduction
Submitting comments on the proposed Regulations for England
The informal consultation carried out in August 2006 did not raise any pertinent issues about the cost implications in relation to the GMP Regulation from enforcement authorities. However, we would welcome your comments on the proposed Regulations at Annex A, 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 implementing the enforcement proposals. Although the costs arising from the need to comply with the GMP 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 GMP Regulation, they should be shown under separate headings from those attributable to the Regulation for England that is the subject of this consultation. If these costs are indivisible or unquantifiable, it would be helpful to have this made clear.