Materials and Articles in Contact with Food (Scotland) Regulations 2007
Tuesday 22 May 2007
The proposed draft Materials and Articles in Contact with Food (Scotland) Regulations 2007 will make provision for the enforcement authorities in Scotland 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.
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
Tel: 01224 285170
Fax: 01224 285168
Responses are requested by: 13 August 2007
The key proposals:
- to revoke The Materials and Articles in Contact with Food (Scotland) Regulations 2005 (SSI 2005 No. 243) in their entirety and remake their provision, taking into account the provisions of the GMP Regualtions
- to devolve responsibility for the enforcement in Scotland of the GMP Regulation to the local enforcement authorities
- to provide for offences under the Regulation and for defences against conviction for committing an offence in particular circumstances
- to provide for penalties that will apply upon conviction for an offence
We would welcome your comments on the proposed draft Materials and Articles in Contact with Food (Scotland) Regulations 2007. The proposed Regulations make provision, in relation to the EC Regulation:
- for its enforcement in Scotland by the enforcement authorities prescribed by the Food Safety Act 1990
- for offences where alleged breaches arise (see paragraph 10)
- for defences that might apply in particular circumstances in the event of offences being alleged (see paragraph 10)
- for penalties that will apply upon conviction for an offence. (see paragraph 10)
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 can be found at the following website address: http://europa.eu.int/eur-lex/lex/en/index.htm
The Food Standards Agency in England, 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.
The time delay between coming into force of the GMP Regulation in January 2007 and its application in law in August 2008, is provided to enable businesses to establish the quality control systems and procedures necessary to demonstrate compliance with its requirements.
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 Scotland and have done so in respect of the Framework Regulation 1935/2004, as sanctioned by The Materials and Articles in Contact with Food (Scotland) Regulations 2005. Thus, the proposed Scottish 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 and 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 6 months or a fine not exceeding level 5 on the standard scale, or both.
Proposed timetable for the Scotland amendment Regulations – dates and introduction
- Public consultation starts 21st May 2007
- Public consultation ends 13th August 2007
- Target date for making the Regulations November 2007
- Target date for coming into force of the Regulations August 2008
Submitting comments on the proposed Regulations for Scotland
The informal consultation carried out in September 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 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.
Data protection form (Word)
Data protection form (pdf)
Publication of response summary
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: firstname.lastname@example.org