New Regulation sets out the requirements for the manufacture and marketing of articles intended to come into contact with food
As we all know, food comes into contact with many materials and articles during its production, processing, storage, preparation and serving, before its eventual consumption. Such materials and articles are called Food Contact Materials (FCMs).
FCMs are either intended to be brought into contact with food, are already in contact with food, or can reasonably be brought into contact with food or transfer their constituents to the food under normal or foreseeable use; it includes direct or indirect contact (ex. Containers for transporting food, machinery to process food, packaging materials, kitchenware and tableware).
Regulation (EC) 10/2011 (the “Plastics Regulation“) sets out the requirements for the manufacture and marketing of plastic materials and articles intended to come into contact with food. These requirements supplement the general rules laid down in Regulation (EC) No 1935/2004 (the “Framework Regulation”) on materials and articles intended to come into contact with food.
Article 16 of the EU food contact material Framework Regulation (EC) 1935/2004 requests the Declaration of Compliance (DoC); more details are set out in Annex IV of the Plastics Regulation (EU) 10/2011.
The DoC is a document delivered by the supplier to his customer at marketing stages up to but excluding the retailer. It has two main aims:
- It confirms to the customer the compliance of the product with the relevant requirements of the Plastics Regulation and the Framework Regulation.
- It provides the consumer with relevant information necessary to establish or check the compliance of the product with relevant legislation.
The purpose of the DoC is to demonstrate that the product is fully compliant with certain regulations and specify the testing methods applied to prove this. Ultimately it comes down to demonstrating that the food contact product is safe and doesn’t contain or transfer restricted chemicals or heavy metals.
It means that all European manufacturers of plastic material that comes into contact with food (including recycled plastics), active and intelligent materials, ceramics and regenerated cellulose film are obliged to issue a DoC for the articles and products they provide. For other types of food contact materials (i.e, paper, inks), DOC is not mandatory at the moment.
The DoC requirement extends all the way from the chemical supplier to any intermediate plastic supplier (suppliers of things like plastic granules and masterbatch) to the supplier of the finished plastic article, to the distributor and finally to the end-user.
According to Annex IV of the “Plastic Regulation”, there are 9 important items that have to be on a DoC:
- The identity and address of the business operator issuing the declaration of compliance. A DoC needs to contain information to ensure that the product is traceable if needed.
- The identity and address of the business operator that manufacturers or imports the plastic material or article. The official name and address of the manufacturing company. If the same company is issuing the DoC and manufacturing/importing the product, points 1 and 2 can be combined into one. This information, together with that contained in point one above will help
determine responsibility and traceability of the FCM if necessary
- The identity of the plastic material or article. Including the trade name, manufacturer’s code, catalogue reference number or any other code identifier that will allow the downstream user to adequately identify and trace the material. You need to know which product/products are covered in the DoC. The products should be specifically identifiable via something like an item number. With regard to the materials used, it is important to declare the type of polymer used in the material. Other materials – such as adhesives, coatings or inks – should also be listed.
- The date of the declaration. This date indicates that the product was compliant with the legislation in place at that time. Given that the legislation is ever evolving, it is possible that it can become more restrictive and compliant products can subsequently become non-compliant due to legislative amendments.
- Confirmation that the plastic material or article complies with all applicable regulations. This confirms that the plastic article is manufactured using only monomers, other substances and additives that are listed and authorised under (EU) 10/2011. The DoC should also mention that the article complies with the overall migration limit (OML). Details about the test conditions, such as any food simulants used and the OM test number according to Annex V to (EU) 10/2011, can be included.
Part of complying with (EU) 10/2011 is that a company’s manufacturing processes must comply with good manufacturing practices (GMP) as set out in Regulation (EC) 2023/2006. This regulation should therefore also be mentioned, if appropriate.
- Information on substances with restrictions in Annex I or II of (EU) 10/2011. This provides the identity of any substances with specific migration limits (SML) in Annex I and II of (EU) 10/2011, or information about the presence of any such substances. There should also be confirmation that the substances featuring SMLs do not migrate above the migration limit, if used under the specified conditions.
- Dual use additives. Dual-use additives are substances that can be used by food business to perform a technological function in food as well as having a function as additives in the manufacture of certain FCMs. Information on the use of dual-use additives should be provided to guarantee they are compliant with the legislation applying to Food Additives/ Flavourings and Food Contact Materials.
- Specifications on the use of the FCM, that includes:
(i) type or types of food with which it is intended to be put in contact; It is important to know which kind (aqueous, acidic, alcoholic, fatty and/or dry) of food the plastic product is intended for use with. Only products that have been tested in the food simulants 10% ethanol, 3% acetic acid and olive oil are suitable for use in contact with all food types. You should be aware of any restrictions in food types.
(ii) time and temperature of treatment and storage in contact with the food; How long can you use the product in contact with food and at which temperatures? This information is crucial for the safety of your food products.
(iii) ratio of food contact surface area to volume used to establish the compliance of the material or article; This is technical information from the test laboratory about the ratio of food contact surface area to volume that has been used to determine the compliance of the product. This figure is often given in dm2/ml.
- Functional barrier. When a functional barrier is used in multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of the Plastics Regulation (EU) 10/2011. This point is only relevant for multi-layer articles that feature a functional barrier. This point confirms that the non-authorised additives behind the functional barrier are not mutagenic, carcinogenic or toxic for human reproduction, and are not in nano-form. It also confirms that the non-authorised substances comply with the detection limit of 0.01 mg/kg.
With this, you should be updated about all the requirements featured in DoC and what to look for the next time you receive one.
In order to allow the exchange of relevant information, the information to be included in the DoC is set out in standard format in Annex IV of the Plastics Regulation.
It is recommended that the DoC and the Adequate Information are issued in one or more EU languages that are easily understood both by the supplier and by the customer. The information given has to be clear and distinct. Information should relate to the actual composition of the material. Several materials with different composition leading to significant differences in reportable substances cannot be covered by one DoC.
One DoC can cover a number of variations of a material or article which differ in their size, shape, thickness or colour or in the source of supply of one or a few of the components, leading to a limited number of variations in the reportable substances, provided that all reportable substances are listed.
The EU Rules on food contact materials can be of general scope, i.e. apply to all FCMs or apply to specific materials only. EU law may be complemented with Member States national legislation if specific EU rules do not exist.
The safety of FCM is evaluated by the European Food Safety Authority (EFSA).
The safety of Food Contact Materials is tested by the business operators placing them on the market, and by the competent authorities of the Member States during official controls. Scientific knowledge and technical competence on testing methods is being maintained by the European Reference Laboratory for Food Contact Materials (EURL-FCM).
Union legislation on food contact materials at EU level aims to:
- Protect consumers’ health
- Ensure the effective functioning of the internal market
An EU declaration of conformity (DoC) is a mandatory document that a manufacturer or his European authorised representative (if the manufacturer is based outside the EU) needs to sign to declare that their products comply with the EU requirements.
By drawing up and signing the EU Declaration of Conformity, the manufacturer assumes responsibility for the compliance of the product by Reg. No 10/2011 on plastic materials and articles intended to come into contact with food (the “Plastics Regulation”).
The EU Declaration of Conformity