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The EU’s Plastics Regulation: What You Should Know

Author: Rachida Semail

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Introduction

The European Union’s Plastics Regulation, (EU) No. 10/2011, on plastic materials and articles intended to come into contact with food, is the most comprehensive EU-wide legislation on a specific category of food-contact material. Since becoming effective on May 1, 2011, it has been amended fifteen times [1], most recently on September 2, 2020. The European Commission (EC) is currently working on the 16th amendment to the Plastics Regulation, which was scheduled to be finalized in 2021. Note also the EC has already started working on a draft 17th amendment to the Plastics Regulation.

I. Scope of the Plastics Regulation

The Plastics Regulation applies to plastics, in monolayers and multilayers, whether or not bound by adhesives, as well as plastic layers in multi-materials and articles (that is, plastics combined with other materials such as paper and/or aluminum). Printed plastic articles and those covered by coatings, in addition to plastic layers or coatings forming gaskets in caps and closures, also fall within the scope of the Plastics Regulation, while ion exchange resins, rubber, and silicone fall outside its scope. These latter materials are ultimately expected to be the subject of separate harmonized legislation.

Strictly speaking, the Plastics Regulation is not intended to regulate the composition of printing inks, adhesives, and coatings (except those forming gaskets in caps and closures); however, as explained in the EC’s Union Guidelines on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Union Guidance on the Plastics Regulation) [2] “the rules set out in the Plastics Regulation for printing inks, adhesives, and coatings used in plastics are only those with regard to their contribution to the migration from the plastic materials and articles (M&A).” In other words, when printing inks, coatings, and adhesives applied on plastic substrates contain substances otherwise listed in the Plastics Regulation, and these substances have assigned specific migration limits (SMLs), the contribution to the migration of those substances from the inks, coatings, and adhesives must be factored in when assessing compliance with the SMLs in the Plastics Regulation.

The Plastics Regulation provides definitions of certain terms, such as of “plastic,” “polymer,” “monomer,” “additive,” “polymer production aid” (PPA), “aid to polymerization,” or “non-intentionally added substances” (NIAS). It is worth mentioning that the Union Guidance on the Plastics Regulation provides for additional definitions that are not found in the Plastics Regulation or other food-contact legislation. These include definitions for “dual-use additive,” “layer,” “masterbatch,” “polymeric additive,” “prepolymer,” “oligomer,” “rubber,” “adhesives,” “coatings,” and “printing inks.” The guidance also provides non-exhaustive lists of functions of substances that are considered additives and PPAs, and a list of categories of aids to polymerization.

II. Positive Listing Requirements and Exemptions

The Plastics Regulation includes a positive list, also known as the “Union List,” which consists of permissible monomers and other starting substances, additives (other than colorants), and some PPAs. Importantly, the Plastics Regulation allows for exemptions from listing on the basis of the functional barrier concept. A “functional barrier” is defined as a barrier consisting of one or more layers of any type of material which ensures that the final material or article complies with Article 3 of the Framework Regulation. This means that the functional barrier doctrine allows for the use of substances not listed on the Union List (except for vinyl chloride monomer). However, certain conditions must be met to make use of the functional barrier exemption; that is, the non-listed substances must:

1) Be separated from food by a barrier;

2) Migrate at a level of less than 10 parts per billion (ppb) (detection limit), noting that this limit applies to groups of substances that are structurally and toxicologically related, and includes set-off transfer;

3) Must not belong to either of the following categories:

carcinogenic, mutagenic, or toxic to reproduction (CMR) in accordance with the criteria set forth in sections 3.5, 3.6, and 3.7 of Annex I of Regulation (EC) No. 1272/2008 (CLP Regulation), or
substances in nano form.

As to substances in nano form, the Plastics Regulation prohibits the use of monomers, starting substances, and additives that are not specifically authorized in nanoform, whether behind a functional barrier or not. This said, the Plastics Regulation does not define “substances in nano form.” Such a definition is provided in the Union Guidance on the Plastics Regulation, which refers to the EC’s definition in its Recommendation 2011/696/EU of 18 October 2011. It is worth noting that the EC’s definition in that Recommendation is broader than the stated intent of the EC when it adopted the Plastics Regulation. Indeed, Recital 23 of the Plastics Regulation aimed at targeting only those substances that are intended to be engineered in nano form, while the definition in the 2011 Recommendation also covers substances naturally occurring in nano form.

Moreover, the functional barrier concept allows for the use of listed substances when these do not otherwise comply with the restrictions and/or specifications contained in the Union List. The Union Guidance on the Plastics Regulation further clarifies that “[i]n principle, substances used behind a functional barrier will have to comply with the general safety requirements of Article 3 of the Framework Regulation and are subject to a risk assessment in line with Article 19 of the Plastics Regulation.”

III. Substances Permitted without the Need for a Listing

The following substances, although not included on Union List, are also permitted on food-contact plastic M&A:

Salts of certain authorized acids, phenols, and alcohols that are listed in Annex II (“Restrictions on plastic materials and articles”);
Mixtures of authorized substances provided no chemical reaction occurs;
Polymeric additives if capable of functioning as main structural component of a final article; and
Pre-polymers and natural or synthetic macromolecular substances and their mixtures, provided that the monomers/starting substances used to synthesize them are in the Union List and they are used as monomers.

IV. Substances Used in Plastics Subject to National Laws

As prescribed by the Plastics Regulation, the use of colorants and solvents must comply with Member State laws, subject to compliance with the mutual recognition principle. Regarding PPAs, those listed in the Union list must comply with the restrictions and specifications set therein. However, the Plastics Regulation does not establish a positive list of PPAs and provides that PPAs that are not listed in the Plastics Regulation are regulated by national laws, subject, again, to mutual recognition. For example, national laws on PPAs exist in Spain under the Royal Decree 847/2011 of June 17, 2011, establishing the positive list of substances permitted for the manufacture of polymeric materials intended to come into contact with food and in the Netherlands under Regulation of 14 March 2014, laying down the Commodities Act Regulation on packaging and consumer articles in contact with foodstuffs.

V. Substances in Plastics Subject to a Self-Safety Assessment

Aids to polymerization used in plastics manufacture and non-intentionally added substances (NIAS) that may be present in food-contact plastics are not subject to positive list requirements whether at the EU or national level.

As to aids to polymerization, the Plastics Regulation recognizes that such substances are intentionally used to initiate the polymerization reaction, such as catalysts, and to control the polymerization reaction, such as chain transfer, chain extending, or chain terminating reagents. However, it stresses that aids to polymerization are typically used in minute amounts and are not intended to remain in the final polymer, such that there is no need to subject them to positive listing requirements and thus leaving it to operators to “risk assess” them in accordance with “internationally recognized scientific principles on risk assessment.”

As to NIAS, which encompass not only impurities that may be present in raw materials used, but also reaction and degradation products that can be formed during manufacture and use of plastics, the Plastics Regulation requires that any potential risk arising from the presence of NIAS must also be assessed based on “internationally recognized scientific principles on risk assessment,” although no specific guidance is provided to industry on how such risk assessment must be conducted.

Given the different regulatory regimes applicable to substances used and/or present in plastics based on function, it is absolutely necessary to first determine the regulatory classification of a substance under consideration to assess its compliance with the relevant applicable rules. Importantly, the Plastics Regulation also requires that substances used in the manufacture of plastic layers in plastic M&A be of a technical quality and a purity suitable for their intended and foreseeable use.

VI. Migration Limits

The Plastics Regulation establishes an overall migration limit (OML) of 10 mg/dm2 for all plastic substances in contact with food. Importantly, the OML covers the maximum permitted amount of the non-volatile substances released from a material or article into food simulants. Specific migration limits (SMLs) and/or residual quantity limits (QM) in the material for certain substances are also specified. Prior to 2016, a generic default SML of 60 mg/kg was applied to substances not subject to an SML, but this was removed in 2016 by the 7th Amendment. Explaining the change, the EC stated that since the migration level from all substances was already subject to an OML, a generic SML was unnecessary and resulted in duplication of migration testing and unnecessary development of testing methods. However, recall that the OML currently only applies to non-volatile substances.

For foods intended for infants and young children (age ranging between 0 and 3 years), the OML is set at 60 mg/kg of food, independent of the packaging size, for plastic packaging specifically dedicated to foods for this age group.

The Plastics Regulation also details the requirements to assess compliance with the applicable SMLs and OML. In cases where worst-case migration calculations or mathematic modeling cannot demonstrate compliance with the applicable SMLs, migration testing is needed and should be performed in accordance with the requirements prescribed by the Plastics Regulation. To show compliance of the final article with the OML, testing with applicable food simulants must always be run under the relevant conditions described in the Plastics Regulation.

VII. Reevaluation of Substances without an SML in the Pipeline

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) has calculated that 451 substances are listed on the Union List that do not have an SML. [3] The EC noted that “for many substances, the absence of a limit is correct because their migration may not be of a health concern.” However, for certain substances, including volatile substances, this may not be the case. [4] Consequently, the EC requested the European Food Safety Authority (EFSA) to identify substances for which an SML may be necessary. Following EFSA’s review, [5] the substances without SMLs have been divided in several groups, as follows:

78 substances excluded from the prioritization exercise as they had previously been evaluated by EFSA as food contact substances.
89 substances where EFSA determined that no SML is needed. The main criteria that deﬁned this group were: (i) a Scientific Committee on Food (SCF) classiﬁcation as List 0 [6] or List 1, [7] and/or (ii) an ‘Acceptable Daily Intake (ADI) not speciﬁed’ by the SCF, and/or (iii) substances that are controlled by existing restrictions and/or generic limits (e.g., salts where the anion is controlled by the general metal-related SMLs on the corresponding cation), and (iv) no conﬂict with subsequent EFSA evaluations in domains other than food contact plastics.
3 substances of high priority for re-evaluation: (i) salicylic acid (FCM substance No 121); (ii) lauric acid, vinyl ester (FCM substance No 436); and (iii) styrene (FCM substance No 193). [8] Note that EFSA has already re-evaluated styrene and the EC is considering the adoption of a risk management decision (i.e., an amendment to the Plastics Regulation or a specific Regulation on styrene).
102 substances classified as medium priority for re-evaluation: this group includes substances for which the information available was not adequate to place them into the “low”, “high,” or “no SML needed” groups.
179 substances classified as low priority for re-evaluation: (i) for which other EFSA Panels have assigned or endorsed an ADI of ≥ 1 mg/kg bw per day (22 substances, mainly food additives and ﬂavoring substances), and/or (ii) having an ADI set by the SCF of ≥ 1 mg/kg bw per day (102 substances), and/or (iii) with a molecular weight above 1,000 Da (39 substances), and/or (iv) classiﬁed by the SCF as List 3 [9] “inert” (26 substances), and/or (v) with high volatility (8 substances).

VIII. Plastic Layers in Plastic Multi-layers

“‘[P]lastic multi-layer’ means a material or article composed of two or more layers of plastic.” [10] A final plastic multi-layer must comply with applicable SMLs identified in the Union List as well as with the OML. When one has to evaluate the compliance of a final plastic multi-layer, it is irrelevant in which layer of the plastic multi-layer a substance subject to an SML is used. This also means that the OML must be met for the final material as a whole, regardless of whether the contribution to the migration will originate from the plastic layer or the other materials applied on those plastic layers, i.e., printing inks, coatings, or adhesives.

A layer in direct contact with the food must always comply with the compositional requirements of the Plastics Regulation. However, a plastic multi-layer material may be composed of a layer that acts as a functional barrier and other layers, behind that functional barrier, which may contain monomers, starting substances, or additives that are not listed in the Plastics Regulation or which do not meet the specifications set in the Plastics Regulation. In such a case, plastic layers behind the functional barrier layer do not need to comply with the compositional requirements of the Plastics Regulation provided that the mandates of the functional barrier concept, as discussed above, are met.

IX. Plastic Layers in Multi-material Multilayers

“‘[M]ulti-material multi-layer’ (MMML) means a material or article composed of two or more layers of different types of materials, at least one of them a plastic layer.” [11] This can be, for instance, a plastic layer combined with a paper layer and/or an aluminum layer. In MMMLs, any layer of an MMML may be a plastic layer, not just the layer in contact with food. Such a plastic layer must be composed of substances listed on the Union List, unless used behind a functional barrier.

Neither the plastic layers in an MMML nor the MMML, as a whole, are required to comply with the SMLs and the OML set forth in the Plastics Regulation. This being said, a requirement of compliance with SMLs and OML may be mandated in Member State legislation, as is the case of the Dutch Packaging and Consumer Articles Regulation. [12] Importantly, the plastic layers must always comply with vinyl chloride monomer’s restrictions, that is, the SML of ‘non-detectable’ (where the detection limit is 0.01 mg/kg [13]) and the residual content restriction of 1 mg/kg in the final product.

X. Declarations of Compliance and Supporting Documentation

Under the Plastics Regulation, operators supplying substances, intermediate products, or final articles (except at retail stage), must issue a Declaration of Compliance (DoC). In addition to the identity and address of the business operator issuing a DoC, the DoC must also include: the identity of the M&A; the date of declaration; confirmation that the M&A complies with the Framework Regulation; and, if a functional barrier is used, that it complies with the appropriate requirements. The DoC must also include “adequate information” on substances used in the M&A or their degradation products, subject to specific restrictions/specifications; dual-use additives, which are subject to a restriction in food; and specifications regarding use of the material (i.e., types of food, temperature, time).

The 8th amendment clarifies that the DoC must include the highest surface to volume ratio for which compliance has been established in accordance with Articles 17 (Expression of migration test results) and 18 (Rules for assessing compliance with migration limits) of the Plastics Regulation, or equivalent information.

The 15th amendment to the Plastics Regulation introduced significant changes to the requirements applicable to the content of DoCs for plastic materials and articles. The Plastics Regulation, as amended, does not define the terms “intermediate materials” or “products from intermediate stages of manufacture.” One has to consider the EC guidance to better understand what these categories cover. It is noteworthy that, per this guidance, a “product from intermediate stages of manufacture” is for instance “a plastic powder, granules or flakes (including “masterbatch”), a pre-polymer (…), any semi-finished material and article such as a film, sheet, laminate, etc., requiring further processing/re-formulation steps to become a “finished” plastic material or article. In short, this is any product which is not a basic chemical and not yet a finished plastic material or article.”

Manufacturers of such intermediate products must identify and provide the concentration of any Annex II substances subject to restrictions that are present “in” their materials, in their DoCs (regardless of whether the substances in question are intentionally added substances (IAS) or NIAS). There is no exemption to this requirement. Manufacturers of intermediate materials must also identify substances for which genotoxicity has not been ruled out in their DoC if the specific migration of the substance in question may exceed 0.00015 mg/kg food or food simulant from the final plastic material or article. This requirement of disclosure of such substances notably raises the issue of the protection of trade secrets. We understand that concerns expressed by industry in this regard might be addressed in the 16th amendment, although this remains to be seen. Note that these obligations for disclosure will become applicable after the transition period set forth in the 15th amendment. [14]

On November 28, 2013, the EC issued a Union Guidance on DoCs [15] addressing: (i) the aim of the DoC; (ii) the DoC for plastic M&A, products from the intermediate stage of their manufacturing, and substances intended for the manufacturing of those M&A; and (iii) adequate information on non-plastic intermediates such as coatings, adhesives and inks that become part of plastic M&A. This Union Guidance also defines several terms that are not defined in the Plastics Regulation, including ‘chemical substance,’ ‘intermediate non-plastic material,’ and ‘final M&A,’ in addition to explaining the obligations of different operators as to their DoCs.

The guidance points out that all business operators in the chain, starting from the suppliers of pure substances, share responsibility for compliance of the finished article. This includes assuring compliance with Good Manufacturing Practices (GMP) for the entire manufacturing process, except for the production of starting substances. General disclaimers without complete disclosure of the composition of the material are not acceptable, and compliance work should be conducted "as high up the manufacturing chain as possible" to avoid duplication. The guidance also specifies that a business operator introducing a substance into a product (i.e., raw materials, intermediate products) intended for food-contact is responsible for that substance—including the impurities of the substance and any reaction products that may be formed—throughout the manufacturing process.

The Plastics Regulation requires that operators keep supporting documentation to back up their DoCs. Such supporting documentation is to be communicated to control authorities upon request. It is not required to be provided to downstream customers. Of course, operators may decide to communicate their supporting documentation, such as migration test reports and other evidence supporting their conclusion of compliance, but such communication is not mandatory based on the mandates of the Plastics Regulation.

In 2017, the EC conducted a “Survey on the use of compliance documentation in official controls and in the supply chain.” While the conclusions of this survey have not been published, the EC and Member States have commented on many occasions that, generally speaking, DoCs are often incomplete. This has also been highlighted in 2017 and 2018 Member State reports published following audits and fact-finding missions on official controls on FCMs. Further, a study commissioned by the EC to support evaluation of FCMs legislation concluded that DoCs do not facilitate the free movement of FCMs on the EU market because (i) there is no quality criteria for a DoC, (ii) their tracking is difficult and (iii) they are not required for non-harmonized FCMs. As a result, the EC has started to work on a draft Template DoC Regulation. It is, nonetheless, uncertain if it will apply to all FCMs or plastic FCMs only and when it is adopted. [16]

XI. Dual-Use Additives

Dual-use additives (DUA) are additives that are permitted in plastics manufacture and that are also authorized as food additives pursuant to Regulation (EC) No. 1333/2008, as amended, or as flavorings pursuant to Regulation (EC) No. 1334/2008, as amended (together the Food Additives and Flavorings Regulations). Additives used in plastics must not migrate into food in quantities having a technological effect in the final foods and must not exceed the restrictions of the Food Additives and Flavorings Regulations in food for which their use is authorized as a food additive or flavoring, even if that limit in food is lower than the SML. The Union Guidance further states that if the chemical identity of a plastic additive matches that of an authorized food additive or flavoring, this suffices to consider it a DUA, regardless of its purity or whether the substance is subject to a restriction in food and/or in plastic. A non-exhaustive list of DUA is provided in that Guidance.

XII. Overview of the Amendments to the Plastics Regulation

The Plastics Regulation has been amended fifteen times, as follows:
1.   Regulation 321/2011 (established restriction on the use of bisphenol-A (BPA))
2.   Regulation 1282/2011 (updated the positive list)
3.   Regulation 1183/2012 (updated the positive list)
4.   Regulation 202/2014 (updated the positive list)
5.   Regulation 865/2014 (correction to the Spanish version of Plastics Regulation)
6.   Regulation 2015/174 (updated the positive list)
7.   Regulation 2016/1416 (updated the positive list and made substantive amendments)
8.   Regulation 2017/752 (updated the positive list and made substantive amendments)
9.   Regulation 2018/79 (updated the positive list)
10.   Regulation 2018/213 (added further restrictions on the use of BPA)
11.   Regulation 2018/831 (updated the positive list and revised several SMLs)
12.   Regulation 2019/37 (updated the positive list, revised several SMLs and assigned food simulants for overall migration testing)
13.   Regulation 2019/988 (correction to the French version of the Plastics Regulation)
14.   Regulation 2019/1338 (updated the positive list)
15.   Regulation 2020/1245 (updated the positive list and substantive amendments, notably to annexes II, IV and V)

The most recent consolidated version of the Plastics Regulation was published in September 2020 and includes changes made through the 15th Amendment.

As mentioned above, the EC is currently working on a draft 16th amendment to the Plastics Regulation. The timing for adoption of this amendment is uncertain. Note also the EC has already started working on the draft 17th amendment to the Plastics Regulation.

Most of the amendments to the Plastics Regulation add substances to the positive list. Anyone can submit a petition to add a new monomer or additive to the positive list. These petitions are first reviewed by EFSA, which will issue, within the time limits set in the Framework Regulation, a formal opinion on the safety of the substance when intended for use with food and any limitations that should be observed. Once EFSA has issued an opinion that the proposed use of a substance is safe, the EC—provided it concurs with the opinion—will add the substance to the positive list through an amendment to the Regulation. However, the EC is not bound to act within a certain timeframe, once the EFSA opinion is available. Importantly, it is only when a new substance and a new use for an existing substance is included in the amendment to the Plastics Regulation that its use becomes lawful.

As the most comprehensive EU-wide legislation on a specific category of FCMs, the Plastics Regulation brought about significant changes in the regulation of plastic FCMs in the EU, although not achieving complete harmonization. This being said, the EC is currently conducting an evaluation of its FCMs legislation to determine whether it is still ‘fit for purpose’ and has published (December 18, 2020) an inception impact assessment explaining its current thinking for the possible future regulatory framework. It remains to be seen how the EC’s future actions may or may not impact the existing Plastics Regulation. Hence, stay tuned to be appraised on the future regulatory changes.

[1] The unofficial numbering of the amendments to the Plastics Regulation was changed by the European Commission in 2017 to reflect the numbering used in the consolidated version of the Plastics Regulation (e.g., M1, M2, M3, etc.). Until 2017, Regulation 865/2014, which corrected the Spanish version of Plastics Regulation, was considered a corrigendum and not counted as an amendment. It is now considered as the 5th amendment and the numbering of subsequent amendments has been changed to reflect this.

[2] Available at EUR-Lex - 02011R0010-20200923 - EN - EUR-Lex (europa.eu)

[3] Review and priority setting for substances that are listed without a specific migration limit in Table 1 of Annex 1 of Regulation 10/2011 on plastic materials and articles intended to come into contact with food, published on 10 June 2020, available at EUR-Lex - 02011R0010-20200923 - EN - EUR-Lex (europa.eu)

[4] Letter of 11 December 2018 from the EC to EFSA re "Specific Migration Limits (SML) for substances used in plastic Food Contact Materials (FCM) - Review. Registered as mandate in the EFSA Register of Questions under Ref. No. M-2019-0056

[5] Review and priority setting for substances that are listed without a specific migration limit in Table 1 of Annex 1 of Regulation 10/2011 on plastic materials and articles intended to come into contact with food, published on 10 June 2020, available at EUR-Lex - 02011R0010-20200923 - EN - EUR-Lex (europa.eu)

[6] List 0, i.e., “Substances, e.g., foods, which may be used in the production of plastic materials and articles, e.g., food ingredients and certain substances known from the intermediate metabolism in man and for which an ADI need not be established for this purpose.”

[7] List 1, i.e., “Substances, e.g., food additives, for which an ADI (=Acceptable Daily Intake), a t-ADI (=temporary ADI), a MTDI (=Maximum Tolerable Daily Intake), a PMTDI (=Provisional Maximum Tolerable Daily Intake), a PTWI (=Provisional Tolerable Weekly Intake) or the classification "acceptable" has been established by this Committee or by JECFA.”

[8] See, Assessment of the impact of the IARC Monograph Vol. 121 on the safety of the substance styrene (FCM No 193) for its use in plastic food contact materials, published on 14 October 2020, available at https://doi.org/10.2903/j.efsa.2020.6247

[9] List 3, i.e., “Substances for which an ADI or a TDI could not be established, but where the present use could be accepted. Some of these substances are self-limiting because of their organoleptic properties or are volatile and therefore unlikely to be present in the finished product. For other substances with very low migration, a TDI has not been set, but the maximum level to be used in any packaging material or a specific limit of migration is stated. This is because the available toxicological data would give a TDI which allows that a specific limit of migration or a composition limit could be fixed at levels very much higher than the maximum likely intakes arising from present uses of the additive.”

[10] Article 3.4 of the Plastics Regulation.

[11] Article 3.5 of the Plastics Regulation.

[12] Section 0.2(d) of the Dutch Packaging and Consumer Articles Regulation.

[13] Article 11.4 of the Plastics Regulation.

[14] The transition clause reads “Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, and which were first placed on the market before 23 March 2021 may continue to be placed on the market until 23 September 2022 and remain on the market until the exhaustion of stocks.” Article 2 of 15th amendment i.e., Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

[15] Union Guidance on Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food as regards information in the supply chain available at https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_plastic-guidance_201110_reg_en.pdf

[16] Ecorys, Study supporting the Evaluation of Food Contact Materials (FCM) legislation - (Regulation (EC) No 1935/2004), available at https://op.europa.eu/en/publication-detail/-/publication/3ae0294b-bc0c-11ea-811c-01aa75ed71a1/language-en