This entry covers legal status within EU of items intended to come into contact with food. If you are involved in any activity related to any stage of manufacture or trade of materials and articles intended to come into contact with food – this article is for you. If you still have any questions – do contact us at: contact@compliantproduct.com.
FOOD CONTACTING ARTICLES – GENERAL REQUIREMENTS
All the general requirements for all kinds of materials intended to come into contact with food are covered by two regulations:
- No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food and
- Commission Regulation (EC) No 2023/2006 – on good manufacturing practice for material and articles intended to come into contact with food (GMP regulation).
Besides those items that are clearly intended for that purpose, such as plates, mugs, forks or baking foil these legal acts also cover all these articles that can reasonably be expected to be brought into contact with food.
WHO IS OBLIGED TO ENSURE SAFETY AND QUALITY OF FOOD CONTACTING ARTICLES?
The regulations are broad and rather unspecific when it comes to addressees. The main one is business defined as “any undertaking (…) carrying out any activity related to any stage of manufacture, processing and distribution of subject materials”[1] and business operator – any person (natural or legal) having control over the business and ensuring that the requirements of those regulations are met[2]. In other words, anyone involved at any stage of manufacture, processing and distribution of materials or articles intended to come into contact with food.
WHAT IS THE MAIN OBLIGATION?
Materials and articles shall be manufactured in compliance with Good Manufacturing Practice. Under normal, foreseeable circumstances they shall not transfer their constituents to food in quantities which could:
- Endanger human health
- Bring about unacceptable change to food composition or deterioration of food organoleptic characteristics.[3]
COMPLIANCE WITH GOOD MANUFACTURING PRACTICE
How the business operators shall ensure that GMP is being followed? According to GMP regulation they are obliged to introduce within their business two main measures: Quality assurance system and Quality control system.
Quality assurance system is an arrangement ensuring that materials and articles are in conformity with the rules applicable to them and quality standards necessary for their intended use.[4]
According to article 5 of the GMP regulation the QAS shall:
- Take into account the adequacy of personnel, their knowledge and skills
- Organization of the premises and the equipment
- Be applied proportionally to size of business (not to be an excessive burden)
- Include specifications referring to selection of starting materials, quality of intermediate and finished materials and articles
- Consists of pre-established instructions and procedures
Quality control system is about application of above QAS measures and checking compliance to them. It shall include monitoring of implementation and achievement of QAS measures as well as identify and correct any failure of such achievement.
Obligation to keep the record is laid down on business operators by article 7 of GMP regulation. It requires that they keep the record both: in electronic and in paper, of all specifications, manufacturing formulae and processing relevant to compliance and safety of finished materials and articles. It shall include QAS instructions and procedures and well as document any QCS measures undertaken.
OTHER VITAL OBLIGATIONS
Are laid down by the 1935/2004 regulation for all articles intended to come into contact with food.
Labelling requirements – based on article 15, applies only to materials and articles not yet in contact with food at the moment of placing on the market:
- If we deal with an article not clearly intended to come into contact with food – it shall bear words “for food contact” or be marked with the glass and fork symbol
- Include any special instructions if necessary for safe and appropriate use
- Name and address data of subject responsible for placing the item on the market (manufacturer, processor, seller)
- Marking ensuring traceability of the material or article
- If we deal with active, intelligent materials – information on the permitted use
At the retail stage all these information shall be displayed either way:
- On the item itself, or
- On its packaging or
- On label affixed to either of the above or
- On a notice in the immediate vicinity of the item
At marketing stage other than retail the required information shall be given: in accompanying documents or on the labels or packaging or the item itself.
If an article is not accompanied by the required special instruction, words “for food contact” or the glass and fork symbol – if there’s need for those, or by information on the subject responsible for placing the item on the market (manufacturer, processor, seller) – it is not legal to further trade with that article!
Traceability. The obligation to introduce traceability system is laid down for various types of products and it’s a win – win instrument. Not only it helps to protect the final consumer, it also works for the best interest of subject responsible for placing the product on the market. Marking the items with some sort of batch or lot code allows to precisely identify any defective article by the consumer. It also allows to limit any market withdrawal to only those defective articles hence limits the liability and potential loss of the producer.
For food contacting articles the obligation of being traceable at all marketing stages is laid down by the article 17 of 1935/2004 regulation. Traceability for these products shall be exercised throughout whole supply chain (it shall allow to identify the businesses from which and to which materials and articles were supplied), by means of labelling and relevant documentation.
CONTROL AND SANCTIONS
In order to ensure that each of above laid down requirements are met for subject products EU member states carry out official controls as well as apply sanctions for any infringements discovered.[5]
DISHWARE INTENDED FOR CHILDREN
There are no particular regulation introducing special requirements for kitchenware meant for children, yet there are two very apt standards highly recommended to be applied to these kind of products:
- EN 14350-1 & -2:2004 Child use and Care articles – Drinking Equipment
- EN 14372:2004 Child use and Care articles – Cutlery and Feeding Utensils
REGULATIONS OF SPECIFIC MATERIALS
Regulation 1935/2004 in its Annex I lays down the list of material groups that may be covered by specific measures and undergo additional requirements referring only to them. These are: active and intelligent materials and articles, adhesives, ceramics, cork, rubbers, glass, ion-exchange resins, metals and alloys, paper and board, plastics, printing inks, regenerated cellulose, silicones, textiles, varnishes and coatings, waxes and wood.
Ceramics are governed by the European Directive 84/500/EEC, introducing clear instruction as regard to migration of lead and cadmium from the article and methods of testing this requirement.
Plastics, including those recycled, are pretty thoroughly regulated by series of legal acts, in particular by the Commission Regulation (EU) No. 10/2011. Its main restriction refers to release of substances named in Annex II: Barium, Cobalt, Copper, Iron, Lithium, Manganese, Zinc), according to indications of Annex V. It sets limit of Migration of constituents – 60 mg/kg of food simulate.
Worth mentioning is also restrictions laid down by: Commission Regulation (EC) No 1895/2005 of 18 November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food and Commission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs.
Paper and board are thoroughly elaborated by policy statement concerning paper and board materials intended to come into contact with foodstuffs of 12 February 2009 including Resolution ResAP (2002) 1 on paper and board materials and articles intended to come into contact with foodstuffs.
As a user of all these materials and articles I wish for myself and all of you the full compliance with above requirements within the whole industry. Enjoy your safe meals!
[1]Regulation (EC) No 1935/2004 of the European Parliament and of the Council – being general regulation to all materials and articles intended to come into contact with food, article 2, 2 (c)
[2] as above, article 2, 2 (d)
[3]as above, article 3
[4]Commission Regulation (EC) No 2023/2006 – on good manufacturing practice for material and articles intended to come into contact with food, article 3 (b)
[5]Regulation (EC) No 1935/2004, article 24 and 25
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