Approval of substances for the positive list of the Plastics Regulation (EU) 10/2011

What are the legislative provisions that require substances used in plastics to be approved by the EU Commission?

The starting point of the legislation on contact materials is that the safety of a product must be demonstrated before it is placed on the market (Framework Regulation (EC) 1935/2004 + Plastics Regulation (EU) 10/2011).

  • Article 5 of the Framework Regulation (EC) 1935/2004 states that the Commission may lay down more detailed provisions on materials by means of specific legislation. If specific legislation has been laid down, a list of approved substances (the so-called positive list) that may be used in the production of the material in question may be added to it.

  • Articles 8 - 12 of the Framework Regulation provide for the authorisation procedures and approval of an individual ingredient used in contact materials for the positive list of specific legislation.

  • The Plastics Regulation (EU) 10/2011 is the specific legislation for plastic contact materials referred to in Article 5 of the Framework Regulation. Annex I to the Plastics Regulation contains a list of approved ingredients in plastic contact materials and their intended uses (monomer or other starting material or additive) in plastic contact materials. In order to have a substance on the list of approved substances in the Plastics Regulation (so-called positive list), an authorisation must be applied for in accordance with the requirements of the Framework Regulation.

Before obtaining authorisation, EFSA carries out a risk assessment of the substance on the basis of the information provided by the operator. The risk assessment requires that the operator has submitted all necessary information on the substance and its intended use to EFSA as an annex to its application. This usually means precise information on the composition and purity of the ingredient used, test results on migrating substances (substances that transfer from the material to the food) and their toxicological and other test results.

The use of a substance subject to authorisation in plastic contact materials is only possible once authorisation has been obtained. The substance shall not be authorised unless it has been duly and sufficiently demonstrated that, when used in accordance with the specific measures applicable to it, the final material or article complies with the requirements of Article 3 of the Framework Regulation.

When must a substance be applied for on the list of authorised substances under the Plastics Regulation (EU) 10/2011?

An application for approval of a substance on the list of authorised substances under the Plastics Regulation (Annex I) must be made through the electronic application system maintained by the Commission in accordance with the following principles:

  • If the substance is not on the positive list of the Plastics Regulation at all, an application for approval must be made for its use.
  • If the substance is already on the positive list, the substance meets the requirements of Article 3a in terms of purity (or the requirements specified by EFSA in its risk assessment) and its use corresponds to the use specified on the positive list, its use is permitted and in accordance with the Plastics Regulation, and no new approval is required.
  • If the substance is a so-called UVCB substance (substance of unknown or variable composition, complex reaction product or substance of biological or other natural origin) as defined in the Plastics Regulation, an application for approval must be made for its use, even if the substance as a pure chemical is already on the positive list.

    In its risk assessment of wood flour, EFSA has taken the position that plant-based substances should be approved for the positive list on a case-by-case basis.

    Due to impurities in the substance, its use is generally not possible as a monomer or other starting substance, but is typically an additive. If a UVCB substance is approved as a pure chemical for use as a monomer or other starting substance, its use as an additive is generally not permitted.

How do I know what the intended use of a substance is in the plastic manufacturing process?

The operator must know the composition of the substances used in the manufacturing of the contact material and any potentially migrating substances, as well as what the intended use of the substance is in the manufacturing process. According to the definitions of the Plastics Regulation (EU) 10/2011 (Article 2, points 6, 7, 8, 9 and 10)

(6) ‘monomer or other starting substance’ means: (a) a substance undergoing any type of polymerisation process to manufacture polymers; or (b) a natural or synthetic macromolecular substance used in the manufacture of modified macromolecules; or (c) a substance used to modify existing natural or synthetic macromolecules;

(7) ‘additive’ means a substance which is intentionally added to the plastic to achieve a physical or chemical effect during processing of the plastic or in the final material or article and it is intended to be present in the final material or article, including substances in a solid state the surface of which becomes bonded to the polymers that constitute the plastic;

(8) ‘polymer production aid’ means any substance used to provide a suitable medium for polymer or plastic manufacturing; it may be present but is neither intended to be present in the final materials or articles nor has a physical or chemical effect in the final material or article;

(9) ‘non-intentionally added substance’ means an impurity in the substances used or a reaction intermediate formed during the production process or a decomposition or reaction product;

(10) ‘aid to polymerisation’ means a substance which initiates polymerisation and/or controls the formation of the macromolecular structure;

Polymerization of a substance in the manufacturing process is a prerequisite for fulfilling the definition of a starting substance. Substances that do not polymerize in their entirety but only attach to the polymer at their surface are additives. This technical difference shows the reasons why a substance is classified as an additive and not a starting substance. If a so-called coupling agent, e.g. maleic anhydride, is used in the manufacturing process to improve the distribution of the substance in the material, this is an established and typical method specifically for additives.

How do I apply for approval for the list of authorised substances in the Plastics Regulation (EU) 10/2011?

An application for authorisation for the use of a substance is made through the Commission's electronic application portal. This requires the operator to obtain an EU login. The Commission has provided instructions on how to make an application on its website:

https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/authorisations_en

EFSA has published guidance on the authorisation procedure for plastic food contact materials on its website:

https://www.efsa.europa.eu/en/applications/substances-plastic-food-contact-materials

EFSA has also, among other things, published guidelines for operators on the submission of data for the authorisation procedure and EFSA's risk assessment:

  • General guidance on the data to provide for plastic FCM dossiers:

https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2008.21r

What are the purity requirements for substances approved in Annex I to the Plastics Regulation (EU) 10/2011?

Article 8 of the Plastics Regulation generally stipulates that substances on the positive list (Annex I) of the Plastics Regulation must be of high purity and technically suitable for the intended and foreseeable use of the materials or articles and the composition of the substance must be known to the manufacturer of the substance. UVCB substances have been granted exemptions regarding their purity.

Article 3a of the Plastics Regulation states what the high purity requirements for substances referred to in Article 8 are:

A substance used in the manufacture of plastic materials and articles shall be considered as having a high degree of purity where all of its constituents correspond to its identity, and it otherwise contains only a minor amount of non-intentionally added substances that individually fulfil one of the following conditions:

  1. they comply with the specifications or restrictions specified in the authorisation of the substance in Table 1 of Annex I, if any;
  2. they have been subject to a risk assessment in accordance with Article 19 and considered compliant;
  3. they have been subject to a toxicological assessment in accordance with the relevant guidance adopted by the Authority, which concludes that genotoxicity is ruled out, and that, on the basis of documented analysis concerning their foreseeable use, characteristics and fate during subsequent manufacturing stages, it can be reasonably assumed that none of the substances will be present in the final plastic material or article at a level that could give rise to a migration such as to their individual presence in food exceeding 0,05 mg/kg;
  4. they have not been subject to an assessment specified in points (ii) or (iii), but to a risk assessment which concludes, on the basis of documented analysis concerning their foreseeable use, characteristics and fate during subsequent manufacturing stages, that it can be reasonably assumed that they cannot be present in the final plastic material or article at a level that could give rise to a migration into food such as to their individual presence in food exceeding 0,00015 mg/kg. 

    For the purpose of point (iii), the individual assessment of genotoxicity may be substituted with a group assessment of genotoxicity, if the assessed substances are chemically related and belong to the same or similar functional groups that could give rise to toxicity, or if the substances are obtained as a mixture representative for migration into food and this mixture is assessed through appropriate methods.

The exemptions for UVCB substances in Article 8 of the Plastics Regulation only apply to the purity of these substances and do not include exemptions for the authorisation process of the substances, which is required by the Framework Regulation. The operator must know the composition of the substance and provide explanations on any migrating substances.

Can wood flour still be used in the manufacture of plastic contact materials?

Wood flour has been removed from the list of authorised substances for use in the manufacture of plastics in the Plastics Regulation (EU) 10/2011 (Annex I) by the amendment to the Plastics Regulation (EU) 1442/2023

The Regulation withdrew the authorisation of the substances “wood flour and fibres, untreated” (FCM substance No 96) because it could not be confirmed that the authorisation in its current form was in compliance with

Regulation (EU) No 1935/2004. In its opinion on wood, the Food Safety Authority EFSA considered that wood-like materials need to be assessed on a case-by-case and species-by-species basis and that the application for authorisation should concern a single wood species and that therefore “wood flour” can no longer be generally authorised.

If operators using wood flour have applied for approval for the wood flour they use by 1 August 2024, they can continue to supply it to the market after 1 February 2025 until the Commission makes a decision on whether to approve or reject the wood flour. Operators can sell out stocks.

However, a new operator cannot start using wood flour, but must first apply for approval from the Commission for the wood flour to be used and its use can only start once approval has been obtained.

Can lignocellulose from wood be used as a plastic additive without approval?

The use of high-purity lignocellulose (FCM 595) is approved in the Plastics Regulation as either a monomer or other starting material, not as an additive. As a general rule, the use of lignocellulose from wood as an additive in plastics is not in accordance with the Plastics Regulation (EU) 10/2011 and its use in the manufacture of the final contact material is not permitted without a separate risk assessment and approval.

This is because it is a so-called UVCB substance, which refers to a substance of unknown or variable composition, a complex reaction product or a material of biological or other natural origin.

The purity of a UVCB substance is almost never that of a pure chemical, but contains impurities due to its natural origin. For example, wood contains a lot of so-called biomass, i.e. extractives and solids that are not present in the original pure chemical and, in addition, due to the collection of wood, it may contain residues of, for example, plant protection products or other environmental contaminants. Due to these extractives, solids and impurities, the substance must be subject to a risk assessment in accordance with the criteria of the Plastics Regulation.

Due to the impurities in the substance, its use is generally not possible as a monomer or other starting material, but is typically an additive. If the substance is approved as a pure chemical for use as a monomer or other starting material, its use as an additive is not permitted.

Can an EU member state grant national exemptions from the requirement to approve substances?

No national exemptions can be granted from the authorisation procedure, as EU regulations are binding on member states as such.

 

Page last updated 11/11/2026