FSA Consultation Letter, 20 August 2004
This consultation seeks views and comments on the Food Safety Act 1990 (Amendment) Regulations 2004 and the General Food Regulations 2004. Responses are requested by: 11 November 2004
The key elements of these proposals are:
The Food Safety Act 1990 (Amendment) Regulations align the definition of 'food' in the Food Safety Act 1990 with the definition in the EU General Food Law Regulation 178/2002, and make consequential changes to the public consultation requirements in Section 48 of the Act. Copies of the Food Safety Act definition of 'food' and the definition in Regulation 178/2002 are included below for ease of reference.
The General Food Law Regulations 2004 provide new enforcement powers in respect of Articles 14, 16 (in so far as it relates to food), 18 (in so far as it concerns food business operators) and 19 of the EU General Food Law Regulation 178/2002. They designate competent authorities and enforcement authorities; make provision for offences and penalties; and make some consequential amendments to the Food Safety Act 1990, in particular Sections 7 and 8.
A formal consultation on the requirements of Regulation 178/2002 was carried out in 2001 and demonstrated that compliance costs would not be significant. As these SIs implement the requirements of Regulation 178/2002, we have not prepared a separate Regulatory Impact Assessment.
These Regulations are intended to apply only in Great Britain. Parallel legislation will apply in Northern Ireland.
EC Regulation 178/2002, laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, came into force on 21 February 2002, although certain key provisions will not apply until 1 January 2005. The draft regulation was subject to an extensive and ongoing consultation process with stakeholders. It was published in the Official Journal No. L 31 on 1 February 2002, and can be accessed via the Commission's web site.
Although as a regulation it is directly applicable in Member States, there was nevertheless a need to review domestic legislation in order to ensure that this was in conformity with both the general principles and the requirements of the regulation. There is also a need to introduce new enforcement powers and penalties in relation to the new obligations on food and feed businesses in Articles 14-20, to apply from 1 January 2005. It is proposed that the necessary changes to domestic food law are effected by means of Statutory Instruments under the Food Safety Act 1990 and the European Communities Act 1972.
i) The Food Safety Act 1990 (Amendment) Regulations 2004
These regulations are being made under the European Communities Act 1972. The only domestic provision the FSA identified that required amendment in the light of the general principles in Articles 5-10 of Regulation 178/2002 was the consultation provisions in Section 48 of the Food Safety Act 1990.
The case law of the European Court of Justice makes clear that it is not open to Member States to retain provisions in national legislation in so far as they 'duplicate, gloss or conflict' with the directly applicable provisions of EU Regulations. The FSA therefore propose to narrow the scope of Section 48 so that it does not apply in cases where the consultation provision in Article 9 of Regulation 178/2002 applies.
The FSA are also proposing to align the definition of 'food' in the Food Safety Act 1990 with that in Article 2 of Regulation 178/2002. This is because they essentially cover the same ground. The FSA's consultations within Government have led them to believe that this change is unlikely to have significant implications.
Please note that the new definition will then automatically apply to other legislation that uses the Food Safety Act definition, for example the Food Standards Act 1999 and the Food and Environment Protection Act 1985, as well as to Regulations and Orders made under all these Acts.
(ii) The General Food Regulations 2004
These regulations are being made under the Food Safety Act 1990, in order to allow greater flexibility in relation to penalties for offences. The regulations are also made under the European Communities Act 1972 in so far as they make consequential amendments to primary legislation. Their main purpose is to provide new enforcement powers in respect of the new obligations relating to food and food businesses, to apply from 1 January 2005 under Regulation 178/2002. These are:
(a) Article 14 - Food Safety Requirements. This prohibits food being placed on the market if it is unsafe, and specifies what this means.
(b) Article 16 - Presentation. This stipulates that the labelling, advertising and presentation of food shall not mislead consumers.
(c) Article18 - Traceability. This requires food businesses to keep records of their suppliers and businesses they supply to, and to make such records available to competent authorities on demand.
(d) Article 19 - Product Recall/Withdrawal. This places obligations on food businesses to recall, and/or withdraw, food from the market if it is not in compliance with food safety requirements, and to notify competent authorities.
The regulations designate food authorities, port health authorities and the Food Standards Agency as the relevant competent authorities and enforcement bodies. The proposed division of responsibilities is set out in regulations 3 and 6. The Food Standards Agency has been included as an additional enforcement body in respect of Articles 14 (Food Safety Requirements) and 19 (Product Recall/Withdrawal/Notification) in certain circumstances. This is to allow, for example, for the flexibility of the Meat Hygiene Service enforcing these requirements in meat plants, where this would be more effective.
As a result of the new requirements of Regulation 178/2002, it has been necessary to make a number of consequential changes to the Food Safety Act 1990, as set out in Regulations 9-15. These include changes to Sections 7 and 8 of the Act, which concern the rendering of food injurious to health and sales of food not complying with food safety requirements respectively. This has been done in order to take account of new provisions in Article 14 of Regulation 178/2002 which cover the same areas. The new provisions are, however, broadly analogous to the existing ones in the Act.
Definition of 'food' in Food Safety Act 1990
1. (1) In this Act 'food' includes:
(b) articles and substances of no nutritional value which are used for human consumption;
(c) chewing gum and other products of a like nature and use: and
(d) articles and substances used as ingredients in the preparation of food or anything falling within this subsection.
(2) In this Act 'food' does not include-
(a) live animals or birds, or live fish which are not used for human consumption while they are alive;
(b) fodder or feeding stuffs for animals, birds or fish;
(c) controlled drugs within the meaning of the Misuse of Drugs Act 1971; or
(d) subject to such exceptions as may be specified in an order made by the Ministers-
(i) medicinal products within the meaning of the Medicines Act 1968 in respect of which product licenses within the meaning of that Act are for the time being in force; or
(ii) other articles or substances in respect of such licenses are for the time being in force in pursuance of orders under section 104 or 105 of that Act (application of Act to other articles and substances)
Definition of 'food' in Regulation (EC) 178/2002
Article 2 - Definition of 'food'
For the purposes of this regulation, 'food' (or 'foodstuff') means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. 'Food' includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC and without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC.
'Food' shall not include:
(b) live animals unless they are prepared for placing on the market for human consumption;
(c) plants prior to harvesting;
(d) medicinal products within the meaning of Council Directives 65/65/EEC (1) and 92/73/EEC (2);
(e) cosmetics within the meaning of Council Directive 76/768/EEC (3);
(f) tobacco and tobacco products within the meaning of Council Directive 89/622/EEC (4);
(g) narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971;
(h) residues and contaminants.