What requirements does legislation set for plastics that come into contact with food?
Plastics intended to be used with food can only be manufactured from approved materials and additives, the article must be tested chemically and organoleptically, and it must be determined suitable for the intended use (EU regulation 10/2011). In business-to-business trade, material shipments must include a declaration of regulatory compliance (art. 15, 16 and appendix IV).
If, under Annex I of the Plastics Regulation, a substance is both an additive and a plastic monomer, what should it be considered as with regard to the composition of the material?
The intended use of the substance in the material determines its relevance regarding composition. The manufacturer of a plastic material should know for what purpose the substance has been used.
Does Plastics Regulation (EU) 10/2011 apply to multi-layer materials in which one of the layers is plastic but the other layers are other materials?
In a multi-layer contact material where only one layer is plastic and the other layers are something else, the Plastics Regulation applies only to this plastic layer in respect of restricted substances. Multi-layer material (from this totality) is not required to comply with the limits in the Plastics Regulation.
What is meant by a polymer type in the declaration of compliance for plastics?
Polymer type means a name determined by the polymer monomer, e.g. polyethylene, polypropylene, polyamide, etc. If the material is composed of several different polymer types, for example, a multi-layer plastic material, then all the polymer types that are present in the material are indicated. For example, like this: PE PP/EVOH/PE.
Have the authorities generally authorised EVOH as a barrier?
The authorities do not authorise materials and their intended uses, only the individual ingredients that food contact plastic may be made from. A definition of what is meant by a barrier is laid down in the Plastics Regulation (Article 3, definition 15). In addition, Articles 13 and 14 regulate the amount of migration from its composition and from the layers behind it. It is the responsibility of the manufacturer to demonstrate the functionality and efficiency of the material as such a barrier.
How should a barrier in multi-layer plastic be indicated in the certificate of compliance? How do I know which plastic layer is a barrier?
In multi-layer plastics materials and articles, the plastic type in the various plastic layers is indicated in the declaration of compliance, e.g. PE-HD/EVOH/PE-LD. If one of the layers of plastic acts as a barrier, it must be indicated. In addition, it must be indicated that the migration behind that barrier is below the limit of 0.01 mg/kg.
There is no list anywhere of materials suitable for a barrier and the manufacturer is responsible for ensuring that the layer which the manufacturer indicates is a barrier meets the functional and other requirements laid down for a barrier. The requirements for a functional barrier are regulated in Articles 11 and 13 of Plastics Regulation (EU) 10/2011. Section 4.4 of the Union Guidance on the Plastics Regulation explains the information to be contained in a declaration of compliance for plastic material (Section 4.4 paragraphs 9 a and b):
For final materials and articles containing plastic layers on the other side of a barrier, the declaration of compliance should contain confirmation that the non-authorised additives and monomers present
- do not meet the criteria for classification as "mutagenic", "carcinogenic" or "toxic for reproduction" in accordance with the criteria set out in sections 3.5, 3.6 and 3.7 of Annex I to the CLP Regulation
- are not in nanoform as defined by the Nanomaterial Recommendation
- confirmation that, under the intended condition of use, the migration of the non-authorised additives and monomers into food or food simulant are not detectable within a limit of detection of 0.01 mg/kg. If such an indication cannot be given under the actual conditions of use, the identity of the substances (chemical name and/or CAS number) must be indicated, as well as any other information needed to allow the food business operator to establish the functional barrier and verify that migration is not detectable.
Where can I find information about surface biocides that have been authorised for use in food contact materials?
There is no official list of these and they are not actually authorised by the European Commission. The substances concerned are assessed by the European Food Safety Authority EFSA and these assessments can be found on the EFSA website. The website has assessments of several organic silver compounds and triclosan. Link to the EFSA website: https://www.efsa.europa.eu/en/publications?f%5B0%5D=im_field_subject%3A70330
What are the dual-use substances used in contact materials and what are their purity criteria? Is their use restricted?
Dual-use substances are food additives and flavourings that are also used in the manufacture of food contact materials. However, dual-use substances used in contact materials are not subject to the same purity criteria (Regulation (EU) 231/2012 laying down purity criteria for food additives) as additives used in food.
However, if a food contact material contains dual-use substances, their migration must comply with the maximum limits for food laid down in Regulations (EU) 1333/2008 and (EU) 1334/2008. If the above regulations do not contain maximum restrictions for these substances in foodstuffs, the amount must not exceed the specific migration limit (SML) set out in Annex I of the Plastics Regulation.
Does the material in which plastic is used as a wood binder come within the scope of Regulation (EU) 10/2011?
Wood fibre is included in the list of authorised components (Annex I) of the Plastics Regulation (EU) 10/2011, i.e. it is a permitted raw material of plastic. The product you describe is a plastic product that is also subject to the requirements of the Plastics Regulation. The Plastics Regulation does not define how much monomer (plastic input) a plastic product should contain, so even if contains just a little, the product is interpreted as a plastic product, i.e. it is classified as a food contact material consisting of plastic material only.
In addition, there are composite materials, so-called plastic composites. These substances are not mixed with each other, but are, however, tightly attached to each other. These composite products are outside the scope of the Plastics Regulation.
Are there any special restrictions on the use of recycled plastic in the manufacture of food contact materials? What requirements must recycled plastic meet?
The use of recycled plastic obtained from a mechanical recycled plastic process is not currently possible in food contact applications other than possibly behind the barrier. The European Commission currently (autumn 2018) has about 140 plastic recycling processes for authorisation (almost all concerning the recycling of PET) and the Commission is now working on authorisation decisions. Once plastic recycling processes have been authorised, the use of material from that process may begin. The EU's plastic strategy is likely to fast track attempts to extend future authorisations to the other commonest plastics such as polyolefins.
The finished recycled plastic must meet the requirements of Plastics Regulation (EU) 10/2011. The resulting declaration of compliance must contain the requirements for additional information set out for that declaration in Regulation (EU) 282/2008 on recycled plastic materials. In the case of recycled plastics, testing must pay particular attention to the detection and risk assessment of NIAS (not intentionally added substances) because recycled plastic can always contain some non-food grade material. The quantity must be less than 5% and should not be added deliberately. Operators should monitor and examine this regularly.
Must plastic processors also have examinations carried out with regard to migrations from products to which they have not added any new ingredients other than those in the plastic granulate? An example of this type of product is a film obtained from the granulate by film blowing and then used to make bags by heat sealing. In this case, no new ingredient has been added to the product in processing. It is assumed that the raw material supplier has had the raw material examined.
Whoever blows the film from the plastic granulate must have both the total migration and the potential specific migration examined if the material contains restricted substances.
What if plastic bags are made of such film by heat sealing, must migration be examined then?
When unprinted plastic bags are made by heat sealing of a film that has been examined, these bags no longer need to be examined for migration.
If, however, labels are printed on the film or some other ingredient, e.g. glue, is added to it, both the total migration and the specific migration of the restricted ingredients must be examined.
Must compliance with Regulation (EU) 1935/2004 to be mentioned in the declaration of compliance for a plastic product when the document states that the requirements of the Plastics Regulation (EU) 10/2011 are met?
Yes, the declaration of compliance must always indicate at least fulfilment of the requirements of Regulation (EU) 1935/2004 and, additionally, indicate fulfilment of the material specific legislation or, in the absence of any, fulfilment of the requirements of some other safety reference that has been chosen.
Does the declaration of compliance for plastics automatically have to indicate restricted ingredients and all the dual-use additives used, or can the declaration only indicate that, if necessary, the information is available subject to a confidentiality agreement?
A declaration of compliance for plastics must always indicate restricted ingredients (name, CAS or FCM number, restriction) and verification that their migration remains below the limits. If there are no restricted ingredients, this must also be indicated. On the other hand, dual-use materials only need to be indicated when they are in the material. However, it is also advisable to indicate that they are not. In this way, plastic material manufacturers show that they are aware of what these substances are and that they may be restricted under food legislation. This increases the operator's reliability from the perspective of the food business operator. This also reduces additional questions put to the contact material manufacturer.