FSA Consultation Letter, 8 September 2006
Informal discussions are taking place with interested parties at the European Union level, on working documents from the European Commission, that could go on to form the basis of harmonised European Union regulations governing materials and articles in contact with food. Responses are requested by: 27 November 2006
The papers that are the subject of this consultation, deal with good manufacturing practice and active and intelligent materials and articles. This describes the current state of play with these documents, the likely timetable as can best be judged at the moment, and seeks your views on what these documents contain.
Good Manufacturing Practice
This working document has come forward in response to instances when chemical migration into food might not give rise to particular health concerns, but which, nonetheless, mean that chemicals are getting into food when they shouldn't. The European Regulation, (EC) No. 1935/2004, requires under Article 3 that all materials and articles falling within its scope shall be manufactured in compliance with good manufacturing practice.
Prior to the adoption of the European Regulation, the United Kingdom and some other EU Member States unsuccessfully sought clarification of the term ‘good manufacturing practice'. The European Commission has now come forward with a text that could provide that clarification in the eventual form of a specific regulation.
The aim of the United Kingdom continues to be to ensure that any such regulation lays down the principles that should be observed by businesses in establishing their own practices, without prescribing how they should do so. This should allow them to achieve the necessary goal, with the flexibility to apply the principles within the circumstances of their business and in proportion to their activities.
Following a request for information and practical examples of good manufacturing practice sent to a limited number of representative bodies in February, the United Kingdom has put forward a substantial revision to the Commission's original working document, that is consistent with our negotiating aim. We are very grateful to those organisations that responded so quickly and positively earlier this year.
The Commission has received this revision very openly, although we understand that not all that we have put forward has been accepted. Of course there are twenty four other Member States involved in this process, so we do not know for sure just yet, what the Commission's next version will look like, but we remain hopeful that it will not be too far from what we have proposed.
Attached is the Commission's original working document together with the United Kingdom's proposal to revise it [See links below] and we should be grateful to know your views before the document finally comes forward for adoption as an EU Regulation.
The possible timetable for this particular document is, as understood at the moment, that the Commission has put a document into its internal consultation process. This enables other Commission Directorates to comment and for a consolidated text to be put to the Commission's legal services for refinement.
Assuming that no major difficulties arise during this process, the resulting document is likely to be put to the Standing Committee on the Food Chain and Animal Health (SCoFCAH) in September.
SCoFCAH is made up of the Member States and the Commission and is the body that would formally vote for the adoption or rejection of a Commission proposal. Recently the European Commission has taken to introducing documents to SCoFCAH in the first instance for the information of the Member States.
This gives the Member States a period of time, three months in the recent past, in which to consider the document before being called upon to formally take a position and to vote on its adoption. This would see the document being taken as a Commission proposal for adoption in December. If adopted in December the text would be published in the early part of 2007 and become law soon after that.
Active and Intelligent Materials and Articles
'Active' materials and articles fall into two categories.
These are likely to be materials or articles containing such things as gas scavengers. These soak up gases that might hasten the deterioration of the packaged food. However, scavenging typical gases that would indicate an 'off' odour from the food would mislead the consumer as to the condition of the food and this is not permitted. The 'absorbers' also include the likes of absorbent pads that soak up or otherwise conceal liquids draining from the foodstuff, for example pads that absorb blood draining from packaged fresh meat.
Active materials and articles are not, under any circumstances, allowed to bring about changes to the smell and taste of the food that could mislead consumers.
'Intelligent' materials and articles are those that monitor the condition of the food or its surrounding environment in the packaging. These include for example colour indicators that monitor the food environment in the packaging for temperature and gases and change colour when the packaging environment changes.
This change of colour is visible from the outside of the packaging and tells the retailer and consumer when the food has spoiled. Others might change colour over a particular period of time and indicate when the ‘use by' date has been reached. As with ‘active' materials and articles, such indicators are not allowed to mislead consumers about the condition of the food through the information they provide.
The working document has been around for some time. However, since two initial bursts of activity, in 2004 and 2005, it has not been the subject of any further discussion while the Commission reviewed all its working documents in relation to the EC ‘better regulation agenda'. This agenda came out of the Lisbon intergovernmental accord in which the United Kingdom had been so active. However, the Commission has now signalled its intention to resume discussion on the working document.
The working document sets out to take further the provision within Regulation (EC) No. 1935/2004 that permits intended migration from food contact materials. It sets out the specific purpose of such migration, the conditions that would apply to the substances that migrate, labelling requirements and requirements for the provision of information within the manufacturing chain. The whole document is ba\sed upon the requirement to satisfy the general requirements of Article 3 of the EC Regulation, that the active and intelligent materials and articles are suitable and effective for the intended purpose and that their components are included in the Community list.
Beyond this, the detail of the text deals with the circumstances under which relevant overall and specific migration limits may be disapplied and of the application of food additive regulations to the migrating substance.
The content of the Community list is spelled out, as is the period for which authorisation shall be granted and for inclusion in the list. The document deals with changes, suspension, revocation and renewal of an authorisation, the detail of the labelling and compliance declaration requirements and transitional measures to allow time for industry initiatives to register with the resulting system.
The likely future course of this working document has not been mapped out at this stage. It is still at the subject of informal discussion between interested parties at European level and, because it has still to go through the Commission's internal consultation process, it is unlikely to be introduced to SCoFCAH before early next year. Introduction at that time could result in formal adoption sometime in the Spring of 2007 but all this may not occur until some time after that.
The following documents are available on this site: