EUROPEAN COMMISSION Brussels, 9.6.2022 SWD(2022) 163 final COMMISSION STAFF WORKING DOCUMENT



EVALUATION

of the legislation on food contact materials - Regulation (EC) No 1935/2004 {SEC(2022) 251 final} - {SWD(2022) 164 final}



Table of contents 1. Introduction 1.1. Purpose and scope of the evaluation 2. Background to the intervention 2.1. Description of the intervention and its objectives 2.2. Baseline and other points of comparison 3. Implementation/state of Play 3.1. Establishment of authorised substances 3.2. Other EU FCM legislation 3.3. Documentation requirements 3.4. National legislation 4. Method 4.1. Short description of methodology 4.2. Limitations and robustness of findings 5. Analysis and answers to the evaluation questions 5.1. Effectiveness 5.2. Efficiency 5.3. Relevance 5.4. Coherence

5.5. EU added value 6. Conclusions Annex 1: Procedural information Annex 2: Stakeholder consultation Annex 3: Methods and analytical models Annex 4: Overview of costs and benefits identified in the evaluation Annex 5: Supporting tables and diagrams Annex 6: Case examples Annex 7: Overview of main specific measures on FCMs that are currently applicable at EU level and their implementation Annex 8: Intervention logic Glossary Acronym Meaning or definition ADC Azodicarbonamide. Used as a foaming agent in plastic gaskets that are used to seal metal lids to glass packaging. AIM Active and intelligent food contact materials (FCMs). Active FCMs extend the shelf-life or maintain or improve the condition of packaged food; they are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food. Intelligent materials and articles monitor the condition of packaged food or the environment surrounding the food. BADGE, BFDGE and NOGE Bisphenol A diglycidyl ether (BADGE), bisphenol F diglycidyl ether (BFDGE) and novolac glycidyl ethers (NOGE) result from the polimerisation process of epoxy resin out of bisphenol A (BPA), bisphenol F (BPF) or novolac and monomers that are not fully chemically bound may migrate into food. BfR Bundesinstitut für Risikobewertung (German Federal Institute for Risk Assessment). BPA Bisphenol A. A monomer used in the manufacture of polycarbonate plastic and epoxy coatings. CEN European Committee for Standardization is an association that brings together the National Standardization Bodies of 34 European countries. CMR Carcinogenic, mutagenic and reprotoxic chemicals. They make up the first and most toxic category of the toxicity classes into which hazardous chemicals can be subdivided, according to EU legislation. CoE Council of Europe. DoC Declaration of compliance. This is a written declaration stating that FCMs comply with the specific rules applicable to them as per Article 16 of Regulation (EC) No 1935/2004. EFSA The European Food Safety Authority is responsible for risk assessment in the area of food safety. EURL-FCM European Union Reference Laboratory. FCMs Food contact materials are all materials and articles which are intended to come into contact with food including those which are already in contact with food and those which can reasonably be expected to come into contact with food or transfer their constituents into food under normal or foreseeable conditions of use as per Article 1(2) of Regulation (EC) No 1935/2004. FTE Full-time equivalent. It is a unit to measure employed persons in a way that makes them comparable although they may a different number of hours per week. The unit is obtained by comparing an employee's average number of hours worked to the average number of hours of a full-time worker. GMP Good Manufacturing Practice. ISO The International Organisation for Standardisation is an international standard-setting body composed of representatives from various national standards organisations. It promotes worldwide proprietary, industrial, and commercial standards. JRC The Commission’s Joint Research Centre. LOQ Limit of Quantification. It is the smallest amount of a substance that can be measured with stated and acceptable imprecision and inaccuracy (e.g. the smallest concentration of a chemical that can be measured with sufficient precision in a millilitre of water). NIAS Non-intentionally added substances. These are impurities in the substances used to manufacture FCMs or reaction intermediates formed during the production process or reaction products or impurities through decomposition. NGO Non-governmental organisation. NGOs are usually non-profit and independent of governments (though often funded by governments) that are active in humanitarian, educational, health care, social, human rights, or environmental causes. NRL National Reference Laboratory. It is required to implement quality assurance and is often the main laboratory where official controls are undertaken. OML Overall Migration Limit. This applies to the sum of all substances that can migrate from the FCM into food (or food simulant). The OML is a measure for the inertness of the material. PET Polyethylene terephthalate (PET or PETE) is a general-purpose thermoplastic polymer. PVC Polyvinyl chloride, a synthetic plastic polymer. RASFF Rapid Alert System for Food and Feed. A key tool to ensure the flow of information to enable swift reactions when risks to public health are detected in the food chain. RCF Regenerated cellulose film. Materials manufactured by the conversion of natural cellulose to a soluble cellulosic derivative and subsequent regeneration, typically forming either a fibre (e.g., rayon) or a film (e.g., cellophane). REACH REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals, which is provided for by Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006. SCF Scientific Committee for Food. The Committee carried out risk assessment work on FCMs prior to the establishment of EFSA. SC-PAFF Standing Committee on Plants, Animals, Food and Feed. SD Supporting Documentation. It must demonstrate that FCMs, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of legislation. It contains the conditions and results of testing, calculations including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance. SME Small, medium and micro-sized enterprise defined by staff headcount, turnover or balance sheet total. SMC Semicarbazide is formed from the breakdown of azodicarbonamide. SML Specific Migration Limit. The amount of substance allowed to migrate into food from the FCM. TDI Tolerable daily intake. A TDI is an estimate of the amount of a substance in air, food or drinking water that can be taken in daily over a lifetime without appreciable health risk. TDIs are often calculated based on laboratory toxicity data to which uncertainty factors are applied. VCM Vinyl chloride monomer, used to manufacture polyvinyl chloride (PVC).



1.Introduction Food contact materials (FCMs) are all materials and articles which are intended to come into contact with food, including those that are already in contact with food and those that can reasonably be expected to come into contact with food or transfer their constituents into food under normal or foreseeable conditions of use – in accordance with the principal basic act Regulation (EC) No. 1935/2004 (hereafter also referred to as the ‘FCM Regulation’). FCMs include food packaging, kitchenware and tableware as well as items used in professional food manufacturing, preparation, storage and distribution. FCMs are manufactured using a wide variety of different materials, including plastics, paper and board, metals, rubber, ceramic and glass; natural materials such as wood and other plant based materials, as well as components used widely in packaging such as coatings, adhesives and inks. FCMs contribute directly to the safe production, processing, transport, sale and ultimately consumption of all foodstuffs placed on the market in the EU. No FCM is completely inert and substances are present in final articles, including those used in their manufacture, those formed from chemical reactions during their manufacture or those present as breakdown products and impurities. They may transfer to food, resulting in exposure of humans consuming that food. Therefore, since 1976 EU legislation has placed basic requirements on businesses concerning the safety of FCMs and substances migrating from them with the aim of securing a high level of protection of human health and the interests of consumers, whilst ensuring the effective functioning of the internal market. The FCM Regulation sets out the modalities for the authorisation of substances used to manufacture FCMs, which must be followed in cases where a specific measure establishes a list of authorised substances for the manufacture of certain FCMs. Further specific measures may then include compositional and testing requirements and restrictions such as the amount of substance allowed to transfer into the food. The FCM Regulation also provides rules on labelling, compliance documentation, traceability as well as inspection and controls. It is complemented by a Regulation on requirements for good manufacturing practices (GMP). The current main EU-specific measure concerns plastic FCMs, which includes a list of authorised substances that may be used in their manufacture. A number of other specific measures also exist, on ceramics, recycled plastics, active and intelligent materials (AIM) and certain specific substances (see also annex 7). In the absence of EU-specific measures, Member States may maintain or adopt their own national provisions on FCMs as per Article 6 of Regulation (EC) No. 1935/2004; such national legislation is in place in many Member States.

The current FCM Regulation does not contain requirements addressing hygiene, environmental concerns or waste management. 1.1.Purpose and scope of the evaluation Although the EU legislation on FCMs was never formally evaluated prior to this exercise, informal monitoring of the legislation has taken place over many years by way of feedback and dialogue on its practical management and implementation, in working group meetings as well as correspondence with EU Member States experts, with industry associations and other stakeholders. This dialogue together with increasing experience with the functioning of the legislation in practice raised several fundamental issues with the existing approach to regulating FCMs at EU level. These encompass the risk assessment and risk management processes, in particular the authorisation of starting substances; the compliance of final articles, information flow in the supply chain, enforcement, as well as coherence with other legislation. Furthermore, the lack of EU-specific rules beyond mainly plastic FCMs is considered by most stakeholders to negatively impact the functioning of the internal market and possibly, the safety of FCMs. In 2017, the Commission’s Joint Research Centre (JRC) published a study (JRC ‘baseline’ study) setting out detailed information on the different FCM supply chains and national measures in Member States. It analysed the effectiveness of such measures on the safety of FCMs and coherence as well as the possible burden of national instruments on Member States and businesses. This evaluation assesses the EU FCM legislation in all EU Member States at the time of its undertaking (i.e. including the UK) as well as its application in EEA countries and Switzerland. This includes the main elements introduced in the first Council Directive 76/893/EEC and maintained in the current FCM Regulation (EC) No 1935/2004, such as basic requirements on safety. It also includes elements that were introduced in 1976, such as the role of the European Food Safety Authority (EFSA) and the approaches taken by the specific measures to regulating FCMs, including assessment and authorisation of substances – primarily in plastic FCMs. As Member States can maintain or introduce national measures in the absence of EU-specific rules according to the FCM Regulation, the evaluation also considers the impact of the presence of national measures. 2.Background to the intervention The size of the European FCM market is estimated to be around EUR 100 billion per annum7, with more than half of this value coming from the plastic as well as paper and board industries. The glass, metal and machinery sectors are also considerable in value, with a significant number of businesses producing and transforming other materials critical to the manufacture of FCMs, including silicones, rubbers, wood, ceramics, coatings, adhesives and inks. Table 2 in annex 5 summarises the distribution of different sized businesses and annual revenue for several sectors. Figure 6, annex 5 provides a generalised overview of the FCM supply chain. Imports make up a considerable portion of the EU market. Although the value of all imports including raw materials is difficult to accurately quantify, as the Combined Nomenclature (CN) codes for imports are not sufficiently detailed, they play a significant role in bringing kitchenware and tableware into the EU, with an estimated value of around EUR 340 million. 2.1.Description of the intervention and its objectives The EU started to legislate FCMs in 1976 with Council Directive 76/893/EEC in recognition of the potential risks to human health from FCMs and potential problems concerning the functioning of the internal market. Since then the legislation has been revised twice; once in 1989 by way of Directive 89/109/EEC and again in 2004 when the current FCM Regulation was adopted. The general objectives pursued by the legislation on FCMs since 1976 are twofold: 1.Provide the basis for securing a high level of protection of human health and the interests of consumers; 2.Ensure the functioning of the internal market. To support these general objectives, the regulation contains a principle legal requirement (Article 3) which states that “materials and articles [FCMs] must be manufactured in compliance with good manufacturing practice, so that, under their normal or foreseeable conditions of use, they do not transfer their constituents to foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof.” The specific objectives aim to ensure the following: 1.FCMs are manufactured to a high-quality standard by requiring the application of GMP for all materials and articles and specific measures on information flow in the FCM supply chain through a declaration of compliance (DoC) and supporting documentation; 2. the interests of consumers are addressed, concerning information on the correct and safe use through labelling requirements such as the wine glass and fork symbol (see right) and prohibition of misleading labelling, advertisement or presentation; 3.enforceability including the removal of non-compliant products from the market through official control and traceability throughout the FCM supply chain; 4.transparency of the safety assessment procedures of FCMs and to ensure accountability and dependency of the authorisation processes;

5.technological progress is taken into account by setting out rules for materials that intentionally change food in accordance with the food law. Annex 8 provides the intervention logic of the original needs, objectives of the intervention and actions taken, as well as the outcome and anticipated impacts with a particular focus on the points above introduced in 2004. The EU legislation on FCMs fits into the wider EU policy on food, chemicals and consumer protection. In particular, following the farm to fork approach governing the General Food Law, it complements Regulation (EC) No 178/2002 (the General Food Law) concerning the safety of foodstuffs, which does not cover transfer from FCMs into food. Official controls on FCMs are within the scope of the food and feed control Regulation (EU) 2017/625 . Other relevant legislation concerning the risk management of chemicals and the protection of citizens include those related to drinking water, medical devices, toys, cosmetics and the general product safety legislation, in which substances found in FCMs may also be regulated (such as phthalates), although there is no direct link between the legislation. Substances used in the manufacture of FCMs are subject to registration requirements under the main chemicals Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), depending on the tonnage used. Additionally, where risks may be identified from substances to the environment as opposed to human health, authorisation of certain substances, including those used in FCMs, may be required. As an alternative risk management approach, a limited number of substances are subject to restrictions set out in Annex XVII to that Regulation, including their presence in FCMs. Of more recent relevance are interactions with major Commission policies on the circular economy (recycling) and the plastic strategy (e.g. the single use plastics Directive), which bans the use of certain single use FCMs such as plastic straws. 2.2.Baseline and other points of comparison In general, the evaluation uses the situation before the introduction of EU rules as a point of comparison. Although some individual rules existed in Member States as far back as 1912, work on FCMs started to develop in the 1950s and 1960s as the use of more synthetic materials began to grow in importance. Some countries such as Germany and the Netherlands introduced specific lists of positive authorised substances, including limits on those substances per polymer type, taking account of the specific technological properties of each material. A more toxicological approach prevailed in several other Member States including Italy, France, Belgium and Luxembourg. In the late 1960s, the Council of Europe (CoE) took steps to design a harmonised approach addressing FCMs by designing a draft Resolution for plastic FCMs. Despite these efforts, many differences amongst the then Member States remained unresolved. For assessing the effectiveness of specific EU measures, primarily plastic FCMs, a comparison has been made with the situation for sectors that to date do not have specific EU measures (sometimes referred to as “non-harmonised”) areas. Where possible, a comparison is made with other EU measures regulating chemicals (see section 4.1), as well as legislation in third countries. 3.Implementation/state of Play The FCM Regulation is directly applicable to all businesses involved in the manufacture, import, processing and distribution of FCMs on the EU market including food businesses selling packaged food. In addition to laying down its scope and providing certain definitions, it sets out basic requirements on safety and changes to food, as described in Article 3 of the FCM Regulation, labelling to ensure the safe use of FCMs by consumers (Article 15) and traceability (Article 17) in the supply chain. All FCM businesses manufacturing FCMs in the EU must comply with rules on GMP, which aim to support compliance and conformity of FCMs throughout the entirety of the manufacturing processes rather than simply at the end. The Commission is empowered to adopt specific measures for the 17 material types presently listed in Annex I of the FCM Regulation, normally in accordance with the Regulatory Procedure with Scrutiny (“PRAC”), following consultation with the toxicological safety section of the Standing Committee on Plants, Animals, Food and Feed (SC-PAFF). The main specific EU measure regulates the composition of plastic FCMs and features a Union list of substances authorised for use in the manufacture of plastic FCMs. Restrictions for these substances used in FCMs are also often introduced to ensure safety, including limits on the content in the final material or for their transfer into food, commonly known as specific migration limits (SMLs). 3.1.Establishment of authorised substances

Building on work already done by Member States, early scientific risk assessments at EU level to inform on the authorisation of substances was undertaken by the Scientific Committee for Food (SCF), an advisory body set up by the Commission in 1974. This was initially achieved for regenerated cellulose film (RCF) in 1983, which currently exists as Commission Directive 2007/42/EC and eventually by the start of the 1990s, a first list of monomers and other starting substances (‘building blocks’ for plastic), authorised for use in the manufacture of plastic FCMs, was established. Since the introduction of the FCM Regulation, the functions of risk manager and risk assessor have been separated to ensure transparency of the safety assessment procedures of FCMs and to ensure accountability and dependency of the authorisation processes. Consequently, the scientific risk assessment work has been conducted by EFSA which replaced the former SCF. The current FCM Regulation lays down specific procedures for the application process for the assessment and authorisation of a substance subject to authorisation, including specific provisions on public access to applications for authorisation, supplementary information from applicants and opinions from EFSA. In order to have a substance assessed, a business operator must compile a dossier of scientific information in accordance with EFSA guidelines, published in accordance with Article 9(2) of the FCM Regulation. The dossier is sent to EFSA via any Member State competent authority and should be assessed by EFSA within six months, subject to the need for supplementary information. EFSA then publishes an opinion indicating whether the substance is safe for its intended use, the conditions under which it can be used as well as restrictions of use for the evaluated substance and/or the [plastic] FCM in which it is used. Taking into account the opinion of EFSA, the Commission may authorise the substance and set out any necessary restrictions for its use, including an SML. Thereafter, any business operator may use the authorised substance in the [plastic] FCM and must comply with any condition or restriction attached to such authorisation. Furthermore, business operators must inform the Commission of any new scientific or technical information, which might affect the safety assessment of the authorised substance in relation to human health. If necessary, EFSA then reviews the assessment. Commission Regulation (EU) No 10/2011 on plastic FCMs (“the plastics Regulation”), includes a Union list of about 900 starting substances and additives authorised for use in the manufacture of plastic FCMs, including specifications and restrictions on their use. No other substances may be used, unless there is a derogation, until they have been assessed and authorised. The plastics Regulation consolidated and simplified the previous two decades’ worth of EU legislation on plastic FCMs, and adapted to technological developments by including rules for plastics used in combination with other materials in so called multi-material multi-layers, such as adhesives or inks, acknowledging the shift in FCMs on the market, and rules on documentation that must accompany the FCMs and how to verify compliance with the rules (e.g. testing). The Regulation also provides certain derogations, for example for substances that catalyse reactions during the manufacturing process. Such ‘aids to polymerisation’ are used in minute amounts and are not intended to remain in the final polymer. They are therefore subject to a risk assessment by the business operator, rather than requiring a full application and assessment by EFSA and authorisation by the Commission. Substances from chemical reactions or degradation may also be formed during the production of plastics – otherwise known as non-intentionally added substances (NIAS). Although they are relevant for the risk assessment, it is not practically possible to list and consider all reaction and degradation products in the authorisation and therefore they must similarly be risk assessed by the business operator according to international rules. Other substances including polymer production aids and macromolecules obtained from microbial fermentation may be included in the list of authorised substances but may also be used without an authorisation, subject to the businesses’ own risk assessment or national law. Such exemptions are laid down in the plastics Regulation and there is no scope for businesses to apply for derogations for those substances for which an authorisation is compulsory, i.e. monomers, other starting substances and additives, excluding colorants. 3.2.Other EU FCM legislation In order to take account of the provisions for waste reduction and thus the need to prioritise recycling, it is necessary to control potential incidental contamination from substances originating from misuse, cross contamination or from the presence of materials that were intended or used for non-food purposes. Therefore, Commission Regulation (EC) No 282/2008 sets out rules for plastic recycling processes and requires the adoption of authorisation decisions addressed to individual recyclers, following an EFSA assessment of their recycling processes. At the time of this evaluation, the Commission was in the process of repealing and replacing the current Regulation and thereafter authorising recycling processes based on applications assessed by EFSA. In the meantime, recycled food contact plastics have been allowed subject to national rules, existing only in a few Member States. Technological developments in the area of food packaging intended to monitor the condition of the packaged food or influence its composition through the release of substances prompted the need to derogate from the general requirements on inertness set out under the FCM Regulation. Regulation (EC) No 450/2009, sets rules for the establishment of a Union list of authorised substances for active and intelligent materials (AIM) and adopts specific provisions on labelling of AIM, declaration of compliance and supporting documentation. Whereas EFSA has undertaken assessments of substances for use in AIM, the authorised list for AIM has not been established. Although both recycling and AIM Regulations are in force, neither has been fully implemented yet for reasons further discussed in section 5.4. Directive 84/500/EEC harmonised the rules on ceramic FCMs at the EU level for the release of lead and cadmium, and sets out conditions for testing the migration of these metals. However, as exposure to lead and cadmium remain too high, considerable reductions in the current limits to safeguard health are needed although many businesses would consequently face difficulties, in particular small or micro artisanal companies, as well as medium sized companies using traditional manufacturing techniques. These considerations are subject to a separate impact assessment process and in general, ceramics and vitreous materials been considered as part of this evaluation process. In addition to the main specific legislation at EU level mentioned above, several additional measures exist, addressing specific substances. These have been introduced following specific concerns or scientific output, including measures on vinyl chloride monomer (VCM), N-nitrosamines and nitrosatable compounds in rubber teats as well as bisphenol A (BPA) and epoxy derivatives in materials other than plastic. Guidance documents have also been introduced in addition to EU legislation, in particular to support understanding and compliance of the plastics Regulation. Figure 2 below gives an overview of all the specific rules and measures in place. Annex 7 contains a description of all specific measures in place at EU level and relevant supporting guidance documents. 3.3.Documentation requirements All EU-specific measures require that FCMs to which they apply must be accompanied by a written declaration (declaration of compliance or ‘DoC’) stating that they comply with the rules applicable to them. Appropriate documentation must also be made available to demonstrate such compliance. For plastic FCMs, these rules apply at all of the marketing stages other than the retail stage, including final articles, products from intermediate stages of manufacturing and for the substances intended for the manufacturing of those materials and articles. The information requirements include the identity of the business operator, the materials and substances used and limitations of the use of the material such as the temperature to which the materials can be subjected. The written DoC must confirm that the products comply with the rules and should be supplemented by appropriate documentation to demonstrate compliance, such as conditions and results of testing, calculations including modelling, other analyses, and evidence on the safety or reasoning demonstrating compliance. Rules for experimental demonstration of compliance are set out in the plastics Regulation.

3.4.National legislation In the absence of specific measures at EU level, Article 6 of the FCM Regulation allows Member States to maintain or adopt national provisions. The 2017 ‘baseline’ study7 by the Commission’s JRC sets out a comprehensive overview of the current national legislation on FCMs in each Member State and identifies multiple pieces of legislation across the majority of Member States, covering most of the materials for which there are currently no EU-specific measures. Some Member States have also introduced national measures on BPA, although there are EU-specific rules, under the safeguard measure provided for in Article 18 of the FCM Regulation. Further risk assessment is currently being carried out by EFSA to determine action at EU level. The impact of the national measures are examined in this evaluation. The FCM Regulation requires Member States to carry out inspections and official controls in order to enforce compliance with the Regulation and to lay down effective, proportionate and dissuasive sanctions in case of non-compliance. Official control work must be carried out in accordance with relevant provisions of Union law relating to official food and feed controls (Regulation (EU) 2017/625). The work is supported by the EURL-FCM at the JRC. Amongst other activities, it develops testing methods, organises inter-laboratory comparison exercises and conducts training courses for the benefit of National Reference Laboratories (NRLs) and experts from developing countries. It also produces guidance documents to support compliance and enforcement work. In contrast to some other EU rules on food, no international regulatory framework currently exists for FCMs such as the Codex Alimentarius. The Council of Europe (CoE) has continued to publish non-binding policy statements on a number of FCMs including metals and alloys and paper and board. International standards also exist for ceramics, both at the level of CEN and ISO, and standards for glass are often available in combination with ceramics. Table 3 in annex 5 gives an overview of the different national measures and materials to which they are applicable. 4.Method 4.1.Short description of methodology The Commission published a roadmap setting out the approach for this evaluation exercise in November 2017. Feedback on the roadmap was received from 26 stakeholders, which was taken into account. A supporting study was commissioned and launched in 2018, undertaken by an external contractor. Additional work to complement the contractor’s report also provides essential input to the evaluation. This includes the JRC ‘baseline’ study7 as well as two supplementary studies done by DG SANTE on controls and information in the supply chain. The analysis further draws on a number of parallel and related EU initiatives on other sectorial or horizontal legislation undertaken recently by the Commission. These include the Fitness Check on General Food Law, the REFIT evaluation work on the mutual recognition (MR) principle, on which FCMs rely, and the Fitness Check on the most relevant chemicals legislation. In addition, EFSA published an opinion on developments in risk assessment, which has also provided evidence that has contributed to the evaluation. Stakeholders participated throughout the entire process, sharing experiences and views on the scope and the approaches set in the FCM Regulation, as well as to help identify any positive or negative effects. The consultation process included a strong representation of scientific and technical expertise from both public (e.g. national authorities) and private sectors (e.g. businesses including SMEs and professional associations) as well as adequate representation from consumer and civil society organisations, including NGOs. Activities included a 12-week public consultation, workshops, an SME Panel Survey and focus group activities. Further details are available in the annexes and on the Commission’s website. 4.2.Limitations and robustness of findings As the original intervention was introduced almost 45 years ago, the reconstruction of the baseline prior to 1976 is largely descriptive and does not readily provide information as points of comparison in order to assess the evaluation criteria, for example impact on costs or health. Similarly, EU-specific measures have been introduced since the early 1980s without impact assessment work, to establish the situation at that time and to provide a quantitative baseline. Nevertheless, the implementation of national legislation in the absence of EU-specific measures beyond mainly plastics has provided a useful baseline, as well as quantitative points of comparison to evaluate the impact of EU-specific measures, in particular on plastic FCMs. It has been difficult to comprehensively quantify costs due to lack of robust data. The scientific studies and the contractor’s report include some relevant data, but stakeholders, especially businesses, were not always willing or able to share information on compliance costs, which are considered confidential. Industry also confirmed particular difficulties in estimating all costs from presence of different national measures. Henceforth, in order to allow a quantitative comparison, surrogate figures or best estimates have been used based on the best available data. To compensate for the lack of hard data, the work encompassed several consultation exercises, including one-to-one interviews, case studies, focus groups and an SME Panel questionnaire, in addition to the 12-week public consultation and workshops. Ad hoc contributions have also been taken into account. The quantification of health benefits could not be properly established due to the lack of available information which is sufficiently robust to establish a causal relationship between the introduction of EU rules on FCMs and health outcomes. However, attempts have been made to investigate the impact of an intervention, such as a restriction or prohibition for a specific substance together with an estimation as to the extent to which the measure may have been beneficial to health. Further analyses have been made to try to gauge the extent to which the legislation may have contributed positively to health, in order to facilitate understanding of the efficiency. 5.Analysis and answers to the evaluation questions In order to carry out the evaluation, 10 questions were prepared covering the five evaluation criteria; effectiveness, efficiency, relevance, coherence, and EU added value. 5.1.Effectiveness To what extent has the FCM Regulation and subsequent implementation achieved its objective of (Q1) providing the basis for securing a high level of protection of human health and the interests of consumers and (Q2) ensured the effective functioning of the internal market in relation to the placing on the market in the EU in relation to FCMs? 5.1.1.Scope of the FCM Regulation, definitions and labelling The FCM Regulation covers materials intended for and already in contact with food but also those which can reasonably be expected to come into contact with food or transfer their constituents into food. Information collected from the consultation work with stakeholders indicates that the scope of the regulation is clear concerning the first two cases (Article 1(2)(a) and (b)). However, around 40% of consultation respondents questioned the clarity of what constitutes “normal and foreseeable conditions of use” (Article 1(2)(c)) including almost all NGOs. The difficulty of fully predicting consumers’ behaviour and to take into account all possible ways they may use or re-use FCMs (see section 5.3 on relevance) was also highlighted in one of the focus groups.

Typical examples include paper towels deployed in the kitchen setting and paper napkins used during the consumption of food (see case example 1, annex 6), where views differ on their status as an FCM. Products not considered to fall within the scope of the FCM Regulation are governed by general product safety or REACH, which do not take into consideration risks arising from the transfer of substances into food. They are also not subject to control under the Regulation (EU) 2017/625 on official controls. Thus if used for food contact they may pose a risk to health as indicated in case example 1. While the wine glass and fork symbol (see section 2.1) should inform consumers about the suitability of an article for food contact, the public consultation shows that 30% of consumers are unclear or unsure of the meaning of that symbol37. Although not statistically significant, a larger sample size (>1000 consumers) taking part in a 2019 survey conducted by the Federation of German Consumer Organisations (vzbv) put this figure at over 50%, similar to the understanding of the AIM symbol (annex I of Commission Regulation (EC) No 450/2009) determined during the public consultation. Earlier survey work on silicon articles on the German market found that when use instructions were given exclusively in the form of pictograms without further wording, those were rarely self-explanatory and often difficult to read because the imprint was blurred and in the same colour as the product. Identification and communication of information to consumers therefore seems partly unclear, which is also identified under the chapter on relevance. In contrast, the wine glass and fork logo is often seen on types of packaging for which it is difficult to re-use with food in any context, such as carton-board packaging, and therefore cannot be aimed at consumers. It raises the possibility that the symbol may be used as a quick and easy way for businesses to indicate legal compliance in the supply chain. The majority of respondents from the public consultation37 consider that the definitions in Article 2 of the FCM regulation are sufficient and clear, with the exception of NGOs, most of whom perceive the current definitions provided by the legislation as not sufficient, although it is not clear on what basis this opinion is formed. However, it may be that the definitions are clear from the perspective of the respondent, but that respondents would not necessarily agree on their meaning. As regards specific measures, discussions frequently occur on definitions of different material types, for example on whether certain elastomeric products fall under the definition of ‘plastic’ in Regulation (EU) No 10/2011, or may rather be considered as ‘rubber’, which are not in the scope of the plastics Regulation. Generally, therefore, it can be concluded that although definitions appear clear, their interpretation depends strongly on the perspective of the stakeholder, leading to possible confusion and different applications of the legislation. 5.1.2.Traceability FCMs should be traceable throughout the distribution chain up to the raw materials to ensure effective action in terms of non-compliance. During the public consultation, almost three-quarters of businesses indicated that they consider traceability requirements to be sufficiently detailed whereas less than half of public authorities agreed with this37. In addition to the FCM Regulation, industry associations have provided guidance that defines requirements to ensure traceability with examples. The Nordic Council of Ministers has developed a traceability checklist on FCMs. Conversely, the evidence from audit and fact-finding missions, as well as discussions with Member States, indicate some general difficulties with accessibility of information across the supply chain, particularly where different businesses operate in different Member States, where coordination between different competent authorities is challenging and where documents are only available in paper format. As well as guidance, stakeholders indicate that traceability is enhanced when a DoC and supporting documentation (SD) is required, in the case of plastic FCMs for example, since these documents contain information such as the name and address of the legally responsible business. In the absence of these specific requirements, there is an indication that traceability may be compromised since businesses must make specific efforts to provide traceability, rather than simply filling in a DoC. However, no examples or evidence have been found of specific problems that have led to major difficulties, for example, in withdrawing or recalling FCMs from the market. Some Member States such as Denmark, Spain (with a reference to an industry guideline), Poland, Slovenia, Estonia and Norway have requirements for registering businesses, which helps as regards traceability. This is touched on again in section 5.1.7 concerning inspections and controls. Overall, there appears to be room for improvement in EU traceability requirements, which are currently supplemented by self-guidance (i.e. standards set by industry bodies) or information in a DoC. 5.1.3.General requirements on safety The general legal requirement on safety laid down in Article 3 of the FCM Regulation has acted to a certain extent as a driver for pushing safety standards and improving the protection of human health. This includes the EU-specific measures in place in addition to the main safety requirement in Article 3 of the FCM Regulation. Member States have introduced national specific rules which support the achievement of safety. Output from EFSA has also helped to facilitate the understanding of safety and compliance22 concerning the migration of substances that can be applied regardless of whether substances are subject to authorisation at EU level. Numerous industry guidelines have also been introduced, which have been designed to ensure safety and facilitate businesses in demonstrating compliance, such as the CEPI Food Contact Guidelines for the Compliance of Paper and Board Materials and Articles. It should be noted that some of these benefits may have materialised even in the absence of Article 3, but not necessarily consistently throughout the EU and to varying degrees. For example, prior to 1976, some Member States had already started to introduce specific rules on FCMs and this appears to be the case for FCMs not subject to specific EU rules. Article 3 in isolation is insufficient to be effective at achieving the aims of the legislation, since it does not define the level of safety expected, how this should be achieved or how it can be demonstrated. Since safety is not absolute and views differ between stakeholders on how to define levels of safety and demonstrate compliance, some stakeholders, in particular industry, find that Article 3 on its own is not effective at providing a level playing field across the EU to support the functioning of the internal market. Others, including NGOs, argue that gaps exist concerning the safety of FCMs. Further analysis on this is carried out in section 5.1.5. The effectiveness of the requirements concerning the effect of FCMs on the organoleptic qualities of food appears questionable because of a lack of agreement and definition of what constitutes a “deterioration in the organoleptic characteristics” of food. There have been unsuccessful attempts at solving issues with sensory science on an EU level, including a JRC workshop in 2011. Furthermore, a key issue identified during the workshop was the lack of harmonised EU standards or guidance on testing procedures. As noted by the JRC ‘baseline’ study7, the extent of approaches is different between different Member States, with some having internal standards, while others following CEN/ISO standards. Case example 2 in annex 6 outlines some practical problems on this topic. Little information is available on the effectiveness of Article 3(2) which prohibits misleading of consumers, aside from recent cases involving so-called ‘eco-friendly’ FCMs. Very few RASFF notifications have been raised on incorrect labelling or advertising of FCMs, which in any case may also relate to safety concerns and therefore non-compliance with Article 15. This may indicate that the requirement is effective at dissuading businesses from misleading advertising, or perhaps reflects the lower priority given to its enforcement. 5.1.4.Specific EU rules introduced under Article 5 of the FCM Regulation Union lists of authorised substances including risk assessment The requirement to generate scientific data, the risk assessment by an independent EU scientific body and corresponding risk management measures introduced by the Commission and agreed upon by Member States has ensured a well-established, well-defined and agreed level of safety that has been achieved for starting substances and additives used in the manufacture of plastic FCMs at EU level. Most stakeholders agree that this process is effective in ensuring their safety, including businesses and Member States according to the public consultation. Indeed, Member States also use the scientific guidance22 provided by EFSA for risk assessment as a basis for their own risk assessment work. The approach has therefore been generally effective at ensuring the safety of starting substances and additives in plastic FCMs. There is a consensus, particularly from businesses involved in the plastic FCM supply chain, that the approach is effective in contributing towards the smooth functioning of the internal market40 . The approach means that rules on the use of starting substances are the same throughout the EU and thus contribute effectively to the functioning of the internal market. The list of authorised substances has provided legal certainty to businesses on what substances can be used, which in turn has facilitated business investments and exchange in the supply chain. The impact appears positive compared with the situation prior to the establishment of the list and in particular in comparison to sectors that trade FCMs for which there is no EU authorised list, as these sectors face different national contexts both at the stage of risk assessment of substances and in their use in plastic FCMs. Development of a Union list has also led to rules on the technical quality and purity of substances, general restrictions such as an overall migration limit (OML) and specific restrictions such as SMLs. These are particularly important mechanisms to ensure exposure to substances stays below a safe level and usually reflect a health-based guidance value such as a tolerable daily intake (TDI) established by EFSA, below which a risk is considered not to be present. In setting an SML, the Commission also takes into account other possible sources of exposure to the substances where information indicates it is necessary. This recognises that consumers may also be exposed to the same substances that are present in other products as well as their presence in the environment including the air. Consequently, these restrictions complement the authorisations and enhance consumer protection. The effectiveness of the approach is however limited in several ways. Currently, over 900 substances are authorised for use in the manufacture of plastic FCMs. This represents no more than around 10% of the overall number of substances used in FCM manufacture, which is broadly estimated to be around 10 000 (although plastic accounts for the greatest proportion of all FCMs on the market6). Not all these substances are toxicological relevant, but the current approach does not automatically focus on those substances with the highest risks. The lack of specific rules beyond mainly plastics is, according to stakeholders, a major problem – either because it does not guarantee safety of other materials or because trade in other materials is hampered by a lack of consistent rules on how compliance to ensure safety should be achieved. The approach is weakened because new scientific knowledge is not reflected in a timely manner in the authorisations. Such knowledge on many substances has become increasingly available over the years, generated for example by REACH requirements, independent scientific research or reviews by other assessment bodies. This is particularly pertinent given that a significant number of the substances that are authorised were assessed decades ago. While a mechanism for update exists that must be triggered by any user of the substances, or can be started by Member States or the Commission, this mechanism does not work. In recent years, the Commission has asked EFSA to re-assess phthalates and styrene, and various requests were received from Member States to re-assess certain substances authorised in plastic FCMs, such as phenol. There is a legal obligation under the FCM Regulation for applicants or users of a substance to report new relevant data, although this has happened very infrequently. While industry has provided new data together with existing data in REACH registrations, FCM dossiers have not been updated at the same time. A possible reason may be that while there is a dedicated applicant for authorisation, once a substance is authorised, there is no authorisation holder; the original applicant may cease to exist and consequently there is a limited responsibility for the update of the substance. Other sectors such as plant protection products, have a built in renewal or review period for the approval of active substances not lasting more than 15 years. Case example 3 in annex 6 provides a practical example.

NGOs as well as the European Parliament have expressed concerns that the current approach in the risk assessment and management of FCM substances does not sufficiently take into account vulnerable populations, unlike other sectorial legislation as identified in the EU Chemicals Fitness Check37. According to a 2016 opinion by EFSA38, a more refined risk assessment of substances is necessary but is not feasible with the current risk management approach due to the consequential demand on resources and practical complexities, such as multiple SMLs for the same FCM. EFSA also considers that the final FCM or article should be evaluated for its safety rather than the starting substances. However, the Regulation is drafted on the premise that it is possible to determine the safety of the final material based on its starting substances. The approach used in the plastics Regulation would therefore require fundamental changes to accommodate for this. A number of stakeholders and in particular NGOs are concerned that the current legislation is not sufficiently effective at taking into account the possible combination effects of substances migrating from FCMs, in particular that the toxicity of combinations of substances could be larger than that of individual substances. Although such phenomena have, for the moment, been observed only in a few cases, it is acknowledged in the EU Chemicals Fitness Check37 as a gap and area in which there is the need for dedicated studies. In 2019, EFSA published guidance for the assessment of this phenomenon (EFSA 2019). This will help in contributing to the risk assessment of the combination effects of migrants released by FCMs. Substances for which a derogation applies and that are not subject to authorisation The effectiveness of the legislation on plastic FCMs is also weakened by several derogations that exist for the assessment and authorisation of substances at EU level. Historically, information has been readily available on monomers and additives that are used in higher concentrations. The process has excluded substances such as polymer production aids, colorants, solvents and aids to polymerisation, which are either used in smaller quantities or not intended to remain in the material. Often, the substances are subject to national legislation and self-assessment, which has led to differences in actions taken across Member States and industry. This is exemplified in the limits and testing methods for colorants set by Member States despite the existence of the CoE Resolution AP 89(1). The Dutch Warenwet and German BfR Recommendations II and VII require a positive listing for aids to polymerisation, but according to industry, when production is sourced outside these countries, it is difficult to receive information on the status of these substances. In the public consultation40, public authorities and businesses expressed the opinion that to provide more effective protection of public health, the Union list for plastics should also include these substances currently covered by derogations. The plastics Regulation focuses on substances used to produce plastics under the assumption that the reacted polymer is substantially less toxic than its starting substances. To manage other substances available in the final product in addition to the overall migration limit, all substances in plastic FCMs including NIAS that do not require an authorisation should be assessed using “internationally recognised scientific principles on risk assessment”. Assessment of NIAS has therefore been the responsibility of industry, which has published recommendations and guidance documents addressing the evaluation of NIAS (ILSI 2016, CEPE 2018, EuPIA 2019). In more recent times, EFSA has started to assess NIAS as far as possible, recognising that they too may present a risk that needs to be assessed. EFSA has provided some partial recommendations on possible ways to assess them38, but a lack of clear and comprehensive EU rules appears to hinder the adoption of a single harmonised approach by all stakeholders. The discovery of cyclo-di-badge as a NIAS in coatings has recently led to challenges because of differences in interpretation between industry and Member States. Despite scientific improvements,, identification and assessment of all possible NIAS are still very challenging, if not impossible in practice. Whilst EU rules require NIAS to be considered, many participants in the consultation work consider that there is insufficient information or guidance agreed upon at EU level. Furthermore, almost 90% of the companies asked40 reported that they do not receive adequate information on NIAS from suppliers and therefore information flow on NIAS is lacking. Case example 4 in annex 6 provides an illustration of the NIAS issue. In conclusion, clearer EU rules and delegation of responsibilities in the supply chain on substances that are subject to derogations are needed to improve effectiveness and to better ensure the safety of final FCMs. Rules for verification of compliance The plastics Regulation is supplemented by guidance documentation, including the EU Guidance on the application of the plastics Regulation with further supplementary guidance on information exchange in the supply chain and testing guidelines developed by the EURL-FCM. According to stakeholders, this guidance is essential to being able to fulfil their compliance work, which in turn ensures safety. Given the constraints of the legal text, these guidance documents have proved popular with industry stakeholders and in particular Member States’ authorities40, who consider them helpful in understanding the Regulation, which is technically complex and demanding to understand and ensuring compliance. Further work on migration testing guidelines by the EURL-FCM is ongoing and eagerly awaited by stakeholders. Specific EU guidance therefore complements the legal requirements enhancing effectiveness in achieving the objectives. A survey on DoC and SD undertaken by DG SANTE in 2017 in which 227 businesses, 59 trade and business associations and 230 public authorities participated, showed that the documentary system based on DoCs and SD has become common practice within the FCM sectors, with the use of DoCs even for FCMs for which there are no EU-specific measures. Businesses report that they usually receive DoCs from their suppliers but that obtaining adequate supporting information through the whole of the supply chain is more difficult, citing confidentiality issues and a lack of knowledge, particularly among SMEs. Checks are mainly limited to visual identity checks with only 11% of business operators analytically checking SMLs/OMLs and the authorisation status of substances. The analysis of DoCs provided shows that most contain basic information and mention compliance with the FCM Regulation and the plastics Regulation. The main shortcomings were in referencing rules on GMP, clear identification of substances used, dual use additives, functional barriers and specifications on the adequate use. Few provided the identity of upstream suppliers. Overall, many DoCs were incorrectly filled-in and incomplete. Trade business associations represent an important channel for information, providing industry guidelines, information and advice on compliance work and legislation to their members. Most mentioned issues in the functioning of information in the supply chain, frequently mentioning the lack of a common structure for DoCs, lack of capacity of SMEs, lack of clarity of responsibilities and varying degrees of knowledge on FCMs along the supply chain. An overview of the main difficulties mentioned in the public consultation has also been summarised40. A study by enforcement authorities has also underlined that following a request by Member States, the chemical industry could not provide adequate supporting documentation showing that they comply with the FCM Regulation. Although it is accepted that downstream users are better placed to estimate likely consumer exposure, they do not currently have access to necessary information that is contained in confidential documentation supporting DoCs of the chemical industry. A mechanism that would relax the confidentiality of this supporting documentation could “contribute to improved assessment of the compliance of the FCM put on the market by downstream FCM users” (Grob 2019). Case example 5 in annex 6 describes a situation concerning a lack of transfer of information in the supply chain. Overall, it can be concluded that some gaps exist in the flow of information along the supply chain and in enforcement by control authorities that undermine the effectiveness ensuring compliance and safety of FCMs. 5.1.5.FCMs not subject to EU-specific rules and/or subject to national rules as provided for by Article 6 of the FCM Regulation and mutual recognition According to the JRC ‘baseline’ study7, some materials are regulated by many different Member States, such as metals or paper and board. However, legislation differs somewhat across the EU. Although there is extensive use of lists of substances, which are either authorised for use or considered safe, which cover close to 8000 substances, less than 20% of substances are in common in three or more Member States (table 4, annex 5). Differences between Council of Europe and Member States’ lists of substances suggest a limited transposition of Council of Europe Resolutions. Where the same substance is regulated in different Member States, the type of restriction (migration, compositional limits, quantity in materials) also varies. For example, 11 Member States have legal provisions for varnishes and coatings, but these have common requirements for only 88 out of 1720 substances, and may differ in terms of the definition of use and their categorisation. Less than half of substances regulated nationally are in lists that EFSA has previously found to be adequately risk assessed. National risk assessment schemes and requirements for the authorisation of substances are not the same in all Member States and often differ from that of EFSA. Their access is limited and often it is not possible to determine in detail how conclusions have been reached, in contrast to the transparency of EFSA’ work. These aspects, together with difficulties reported by businesses to access information and their availability only in national languages, are considered a large burden for industry and barriers to trade. It leads industries to seek external legal advice, which results in lengthier authorisation processes and delayed market access. It also results in greater focus on certification and accreditation systems at industrial level. According to various sectors, they have increasingly tended to seek global food contact compliance in non-EU legislation to overcome the lack of coherent rules at EU level. The results are substantiated by the findings of the supporting study including the public consultation40 and specific difficulties for the rubber sector are set out in one case study.

Where no specific EU rules exist, the mutual recognition principle should apply to ensure market access for products that are not subject to EU harmonisation. However, there is a widely shared view among FCM industry representatives that the mutual recognition system is not working properly in the sector (see figure 3 below), which constitutes a barrier to the functioning of the internal market. In many cases, rules in one Member State may differ from those in another since according to EU law, justification can be given based on overriding reasons of public interest and which are proportionate to the aim pursued. The application of the mutual recognition principle has always been challenging and typical barriers to effective mutual recognition stem from Member States’ application and knowledge of the principle, and from companies’ lack of awareness of the principle. The staff working document (SWD) on the evaluation of mutual recognition also highlights the need for more reliable monitoring tools and better data on the functioning of the mutual recognition system. Both the evaluation and impact assessment for a new regulation concluded that the interrelationship between the FCM Regulation and the mutual recognition Regulation (EC) No 764/2008 was not clear to economic operators, in particular in terms of the principles and scope of application of the latter and its ability to facilitate compliance with specific national rules. Case example 6 in annex 6 gives an overview of some practical examples where additional costs and burdens to industry have been experienced. Since the evaluation of the mutual recognition principle, a new Regulation 2019/515 has been adopted and has applied since 19 April 2020. It has sought to address the problems established by the evaluation, including the assessment procedure to be followed by competent authorities when assessing goods as well as a business-friendly problem solving procedure, based on SOLVIT, that includes the possibility of an assessment from the Commission on the compatibility of a decision restricting or denying market access with EU law. This should help FCM businesses, but the impact of these changes will need to be assessed in time. Overall, the situation created by a lack of EU-specific measures beyond plastic FCMs, and a multitude of national measures has created legal uncertainty, barriers to businesses and may create confusion over required or acceptable levels of safety. 5.1.6.Good Manufacturing Practice (GMP) Many stakeholders consider that the current EU rules on GMP are not sufficiently detailed in the legislation to enable FCMs to be manufactured to a high standard, particularly Member States’ authorities and most NGOs40. However, the introduction of basic rules has prompted industry to address GMP in different sectors, and only in very specific cases has EU intervention been necessary, in particular in the case of preventing migration of printing ink23. Since 2006, sectorial GMP guidelines have been introduced by industry, that are better adapted to the specific supply chain situation and needs and with specific expert knowledge. Examples of such sectorial GMP guidelines include those issued by the ink and paper and board45 industries. Indeed, the most comprehensive GMP guidance documents appear to be those for paper and board, which also include guidance from Nordic countries and which are considered useful in helping to ensure GMP for this sector. The Swiss Packaging Institute (SVI) has developed and revised a checklist for industry to assess DoC, which is used by inspectors for controls. However, it is not always clear whether these guidelines are used in practice by the members at national and local level, especially among SMEs. There are references to GMP in a number of Member States and a full guidance has recently been developed by Italy, although it has not been possible to evaluate the extent to which this is effective. Sector specific guidelines are also provided by some Member States, although these are often conceptual and require further elaboration by industry. Stakeholders including NGOs and some interviewed business associations have expressed a preference for integrating GMP requirements into specific measures rather than having a separate GMP Regulation, i.e. that GMP is not sector specific enough at present to be sufficiently effective. Moreover, stakeholders (from all categories) mention difficulties in ensuring that, in the case of products imported from third countries, the manufacturing process is in line with GMP requirements. Results from the public consultation, across all categories, show that most respondents are concerned about the application of GMP in third countries40. In conclusion, the basic requirements on GMP have stimulated industry to implement self-guidance on GMP with more sector specific rules. However, there is some uncertainty on the extent to which GMP guidelines are taken up and used in practice. 5.1.7.Inspection and official controls by Member States’ competent authorities The Regulation (EU) 2017/625 on official controls explicitly captures the manufacture and use of FCMs: FCM operators are explicitly included. Controls should be undertaken on products, substances and materials that may influence food safety, including food processing equipment and packaging. Official controls should include an examination of compliance already established by the business operators and procedures on GMP. Member States’ competent authorities must take account of previous records on compliance as well as the reliability and results of businesses’ own controls that have been performed by themselves, or by a third party at their request, including, where appropriate, private quality assurance schemes, for the purpose of ascertaining compliance. Member States’ competent authorities must draw up and keep up-to-date a list of FCM business operators. Non-compliances are typically reported via the Rapid Alert System for Food and Feed (RASFF) or the Administrative Assistance and Cooperation (AAC) system. Typically, RASFF notifications on FCMs make up a small proportion of all RASFF reports. To some extent, this may reflect priorities set by Member States on controls. However, the findings are also generally limited by a significant lack of accredited methods for authorised substances in plastic FCMs because of the large number of substances and combination of those substances with plastic matrices, conditions of use, etc. This is also discussed later in section 5.3 on relevance. Member States’ competent authorities are therefore in reality enforcing only a very small number of the SMLs set for different substances (<5%) that have high visibility and/or for which dedicated measures exist or are easy to test for. Member States are therefore able to carry out inspections and controls in a very limited capacity. Performance of Member States Commission visits and audits of 22 national control systems between 2007 and 2011 found that many (mainly new) Member States had only just started implementing controls and further efforts were needed to develop the control systems, like an elaboration of specific guidelines, upgrading of laboratories and specific training. Moreover, competences were not sufficiently clear, resulting in either a lack – or an overlap – of official controls. Risk-based official controls at FCM manufacturing level were not well established and staff was lacking sufficient training on FCM related issues, such as assessments of documentation, traceability systems and GMP principles. Follow-up audits in 2017 and 2018 together with two workshops confirmed that deficiencies remained, with the following conclusions: ·Official controls on FCMs in Member States are in general weak, not sufficiently effective and considered a low priority.

·Controls are often limited to the verification of the presence of the DoC, with inspectors rarely having the expertise to verify its content. ·Businesses involved in the FCM chain can only be identified to a limited extent. ·Underlying problems identified include: ØLack of regular dedicated inspections; ØLack of expertise and experience at the front-line control level; ØInability to identify all relevant businesses; ØLack of comprehensive checklists; ØLack of guidance documentation, including on the evaluation of DoCs; ØLack of effective training for inspectors; ØLaboratories have neither the resources nor the ability to perform analytical checks on samples not foreseen by established control plans; ØEnforcement measures and/or sanctions are not systematically imposed; ØPoor documentation of controls and few records of cases of non-compliance hampers future risk-based planning; ØIndustrial equipment is often overlooked during official controls. Overall, the current systems of official controls cannot adequately or fully enforce the requirements of the legislation, although this does not imply that FCMs are unsafe. One key problem, the lack of a systematic registration system for businesses, currently only in place in eight Member States, is expected to be helped through Article 10(2) of Regulation 2017/625 on official controls (which entered into force on the 14th December 2019) introducing a more systematic registration of businesses, which should allow competent authorities to better plan inspections and controls for all relevant companies. 5.2.Efficiency Q3. What are the quantifiable benefits, taking into account resources (cost, time, etc.) to stakeholders, including: ·Consumers (e.g. health benefits); ·Businesses, including specifically for SMEs and microbusinesses (e.g. in demonstrating compliance, market access); ·Member States' competent authorities (e.g. in ensuring safety and control of FCMs)? 5.2.1.Human health benefits There is some available literature supporting adverse health effects from exposure to a limited number of hazardous substances that have been found to migrate from FCMs, for which rules have been introduced, such as phthalates. However, these adverse health effects occur from long-term exposure, where exposure also occurs from other sources such as environmental or other consumer products and where other interventions may have occurred. This makes it impossible to directly link possible health benefits of specifically regulating FCMs and to quantify the overall health benefits of the FCM Regulation. However, an attempt has been made to estimate the magnitude of some plausible health benefits from a limited number of substances regulated under FCM legislation for which information is available. FCMs are known to be a contributing source and even where the contribution from FCMs to overall exposure is assumed to be very small (~1%), the magnitude of health cost benefits for these substances is likely to run into hundreds of millions of euros. Based on reasonable assumptions, the same estimations may be applied for a number of other substances that migrate from FCMs, although the extent of the health benefits will vary, and many will have less hazardous properties or migrate in smaller amounts resulting in lower exposure. Lead has long been used in ceramic ware, both in glazes and in decorations. However, it is a toxic substance that can cause a wide range of diseases, affects reproduction and the nervous system, as well as the (cognitive) development of children. A study from 2013 estimates that the health costs caused by exposure to lead amount to some USD 970 billion (EUR 820 billion) annually in low and middle-income countries (LMIC), compared to USD 55 billion (EUR 45 billion) in Europe. This translates to approx. USD 170 (EUR 144) per capita in LMIC, compared to less than USD 110 (EUR 93) in Europe. The differences between the costs attributed to stricter legislation in the EU, extrapolating the per capita difference to the EU population, overall implies health benefits stemming from EU legislation of approx. USD 31 billion (EUR 26 billion) per year. Human exposure occurs mainly via food and water, with minor amounts via air, dust and soil. Although a significant proportion of exposure via food is likely to occur due to environmental contamination, it is known that lead can migrate in high amounts from ceramic ware and EU legislation exists setting limits on the amount of lead that may migrate from ceramic FCMs. An estimate of the exposure to lead from FCMs accounting for around 1% of total exposure was considered reasonable, which in turn would equate to approximately USD 310 million, or EUR 285 million per year in cost savings from the legislation. This indicates that the health benefits from restricting lead in FCMs could range in the hundreds of millions of euros, particularly over the period since the rules were introduced. Phthalates have long been used as softeners or plasticisers in plastic. The study on the cumulative health and environmental benefits of chemical legislation estimates that restrictions on phthalates resulted in benefits for reproductive health of approx. EUR 130 billion between 1996 and 2008 cumulatively, or about EUR 11 billion annually. These values are based on the lower bound reported by the study. While the study was not able to establish a causal relationship, the authors note that the reduction in health costs from diseases possibly caused by exposure to phthalates occurred at the same time as increased regulatory activity. Given that FCMs are one significant source of exposure of consumers to phthalates, it is likely that a significant share of the benefits reported above can be traced back to restrictions on the use of the substances in FCMs. For example, even if legislation on FCMs contributed only 1% to the estimated health benefits, this would imply health benefits of about EUR 110 million annually for this group of substances. A report published recently by ECHA on the costs and benefits of REACH restrictions proposed between 2016 and 2020 also gives clues as to the possible impact of restrictions for the same substances restricted in FCMs, even if the restrictions are not comparable. Three of the four phthalates restricted under REACH are also restricted, albeit to a lesser extent, by the FCM plastics Regulation. According to the ECHA report, monetised benefits of restricting bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP) (the four phthalates) are estimated to outweigh the costs by more than 10 times. The benefits are estimated at EUR 235 million while the costs are about EUR 17.6 million per year in the worst-case scenario. Vinyl chloride monomer (VCM) is produced industrially, primarily to make polyvinyl chloride (PVC); PVC is used to make a variety of plastic products, including pipes, wire and cable coatings, and packaging materials. Exposure to VCM is associated with an increased risk of a rare form of liver cancer (hepatic angiosarcoma), as well as brain and lung cancers, lymphoma, and leukaemia. In the mid-1970s, VCM was also identified as a contaminant of foods packaged in PVC material. In 1978, the EU introduced a restriction on the presence of vinyl chloride monomer in, and possible migration from, FCMs prepared with vinyl chloride polymers or copolymers. In turn, more stringent manufacturing specifications for PVC were implemented and such contamination decreased substantially; as a result, VCM has not been identified in food, pharmaceuticals or cosmetic products in recent years. Whilst it is not possible to quantify the health savings from the EU intervention, a report prepared for the Commission in 2011 on possible impacts of amending EU legislation on VCM for workers, indicates that health savings run into hundreds of millions of euros. Whilst the risks to workers are greater than they are to the average consumers, workers represent a sub-section of the population, whereas all EU citizens are consumers who may otherwise have been exposed to VCM from food packaging over the years subsequent to when the EU intervention was introduced. Therefore, a reasonable assumption is that restrictions on VCM may also have resulted in health savings of hundreds of millions of euros in the last 40 years.

Prevention, control and reaction in Member States To estimate the health benefits in a semi-quantitative way, a composite index was developed. This index is based on three factors, which are considered to contribute to the protection of consumer health in Member States: prevention, controls, and reaction. Further, table 5 in annex 5 reports on the results of the analysis. The score for prevention is based on the share of FCMs covered by national legislation (excluding harmonised materials). The results indicate that 14 out of 25 countries have a good overall score, meaning that they got at least 70% of the potential weighted score, while 12 countries received an overall weighted score of below 70%. However, for some of them the information available is very limited. Data availability was too limited for three countries to yield meaningful results. The analysis found a good weighted score for five countries only, reflecting those with measures in place covering many material types. These scores are likely to be conservative, as they do not account for the potential contribution of one Member States rules to another. The control score captures whether Member States have the resources, expertise, analytical equipment and procedures in place to perform sufficient controls. Scores are mixed, with good scores in just above half of Member States, suggesting that the benefits yielded from controls remain limited, at least in some countries. A common obstacle pointed out across audit reports is the limited number of controls performed each year. In addition, inspectors often lack adequate training to perform controls. The reaction scores indicate that there are good structures in place in all Member States except one, which enables them to react swiftly to RASFF notifications, all notifications are answered, and sanctions are applied that should motivate compliance with the legislation. These aspects provide benefits for consumers by ensuring the protection of human health, and non-compliant FCMs will be quickly removed from the market. Overall, the exercise indicates that health benefits stemming from the EU Regulation on FCMs are not maximised. 5.2.2.Economic benefits for consumers The harmonisation of rules under the FCM Regulation and subsequent material-specific legislation likely yields economic benefits for consumers too. Harmonisation should reduce barriers to trade within the EU and, consequently, lower production prices for packaging and other FCMs. This may translate into lower prices for consumers. While the cost and price reduction are likely to be very small for an individual product, they may account for a sizeable sum when aggregated at EU level. An attempt was made by the contractor to collect evidence to indicate a positive (or negative) effect of the FCM legislation on consumer prices, but none could be found. 5.2.3.Benefits for businesses The public consultation40 results showed that difficulties in placing FCMs on the EU market appear far less frequent for FCMs subject to specific EU measures (plastic FCMs) than for FCMs that are not, indicating that further harmonisation of FCM legislation has a positive effect on intra-EU trade. Similarly, about two-thirds of respondents to the SME survey indicate that further harmonisation would enhance the functioning of the internal market. Furthermore, trade data was examined and showed a correlation between the introduction of EU rules on plastic FCMs and an increase in intra-EU trade, although no firm conclusions can be drawn since factors other than the legislation might also affect trade at the same time as the legislation was introduced, such as demand and economic viability of manufacturing plastic. Harmonised risk assessment work at EU level has also saved industry costs, which have been estimated by the number of times the application would need to have been filed with Member States. Based on the JRC ‘baseline’ study7, an average of 3.7 Member States perform risk assessments per material group. The administrative costs to prepare a dossier are estimated to be approximately EUR 60 000 per dossier on average, taking into account its preparation, translation, etc. These are taken as the basis to estimate cost savings. Table 6 in annex 5 illustrates total costs savings for the 95 dossiers assessed at EU level by EFSA between 2014 and 2018. This shows that total cost savings could be anywhere up to EUR 15.4 million or EUR 162 000 per dossier. This does not take into account the costs for scientific work required for the assessment, which are several folds higher. It is assumed that applicants would be able to re-use the toxicity studies and analytical testing, although in some cases additional tests or criteria may need to be fulfilled. Member States have in some cases diverging requirements, which also results in re-doing studies or generating new ones. The true savings for a harmonised EU system may therefore be much greater. Further cost savings have been identified insofar as the Union list of authorised substances is not applicant specific and reduces the costs for businesses as they can use substances without generating risk assessment data and submitting applications of their own. As discussed in one of the focus groups of the evaluation, this is particularly important for SMEs as they otherwise lack resources to determine compliance without such legal certainty, compared with larger industry players. Evidence also remains inconclusive when the analysis is undertaken at the country-level. In September 2017, the German BfR published new recommendations on paper based FCMs. This “intervention” was used to explore imports of paper based FCMs into Germany from other EU countries in the months before and after the publication of these recommendations. However, it was not possible to identify a clear effect on the trade of these products. Overall, cost savings from the EU legislation are limited and relate to the existence of specific measures, in particular for plastic FCMs. 5.2.4.Benefits for Member States’ competent authorities According to EFSA, it spends an average of around EUR 430 000 to EUR 450 000 per year on risk assessments. This covers the three categories of FCMs for which risk assessments are currently actively performed at EU level (and for which authorisation is required or foreseen – plastic, recycled plastic and AIM). Three scenarios and estimates are provided in table 7 in annex 5 and from this, estimates suggest that cost savings from harmonised risk assessments range between EUR 450 000 and EUR 1.2 million per year for Member States who otherwise undertake their own risk assessment work. The harmonisation of provisions on FCMs at EU level requires cooperation and exchange of information among competent authorities in the Member States. For example, authorities meet regularly in the scope of PAFF meetings to exchange views and direct risk management actions. The EURL-FCM contributes to the improvement and harmonisation of methods of analysis through its network with national reference laboratories. However, it is not possible to quantify or even monetise the benefits of this enhanced cooperation and knowledge sharing. Among others, the following organisations facilitate exchange and cooperation: ·ESCO: The EFSA Scientific Cooperation working group is composed of experts from a selected number of Member States. The EFSA Scientific Cooperation working group supports the collection of information on non-harmonised FCMs across the EU; ·FCM network: The Scientific Network on Food Contact Materials is a permanent group of representatives of Member States. EFSA oversees the organisation of the group. It comprises all Member States, as well as the Commission including the JRC (EURL-FCM), Council of Europe, with EEA countries as observers.

Overall, cost savings for Member States from harmonised risk assessment currently appear limited. Q4. What are the quantifiable burdens, taking into account resources (cost, time, etc.) to stakeholders and are there aspects that could be simplified to improve efficiency? 5.2.5.Burdens for stakeholders The estimate from this evaluation suggests annual costs to industry linked with the FCM legislation in the region of EUR 3.1 billion per year (or around 3% of turnover). This is detailed further in table 8 in annex 5. The dimension of costs varies greatly depending on the position of businesses in the value chain and the type of the material. Based on the input received from stakeholders40,104 and previous research, the cost items were grouped and categorised in line with the framework developed in the Commission’s better regulation toolbox. Two types of costs are considered in the analysis: (1) compliance costs, including dossier preparation, GMP, and analytical testing, which are borne principally by manufacturers and convertors and (2) administrative costs. It should be noted that compliance and administrative costs here are assumed to be linked with the FCM legislation. However, the business-as-usual (BAU) factor, which describes the share of activities that companies would have performed (and thus costs they would incur) even if the EU legislation on FCMs had not been introduced, is likely to account for some of this. Certain activities and production standards are desirable for companies anyway, due to self-regulation in the sector and because business partners along the value chain ask for certain information. For example, even though DoCs are not mandatory for FCMs without specific EU measures, several industry associations developed similar documents for their sectors to ensure transparency and the information flow along the value chain. Plastics FCM industry Overall, estimates developed during the evaluation suggest that the total costs of the FCM legislation for the plastics sector amount to 0.2% to 2.9% of the sector’s turnover. An interview with representatives of the sector supports the upper bound, reporting costs amounting to 3% to 4% of turnover, or in the region of EUR 1 billion. Table 9 in annex 5 illustrates the overall estimated costs for the plastics sector. Specifically for compliance costs, the upper bound estimate is in the region of EUR 650 million annually, which represents around 2% of the turnover. An interview with industry representatives to discuss the estimates suggests that the actual value is indeed likely to be closer to the upper bound. Table 10 in annex 5 reports specifically on the cost estimates for dossier preparation, which were collected from different sources for triangulation. PlasticsEurope provided cost estimates ranging between EUR 200 000 and almost EUR 2.2 million for a dossier, including the administrative costs to prepare a dossier. This correlates with the findings of the REFIT Evaluation of the General Food Law35. The association also provided a breakdown of costs among the key cost items of dossiers – toxicity testing, analytical testing, and additional resources. This breakdown suggests that toxicological tests are the key cost driver but vary significantly depending on the degree of testing required, with requirements and thus costs increasing the more a substance is likely to migrate. The costs reported by industry are generally supported by other estimation techniques, except for case study 1 (see annex 2), which used older cost estimates. From when the plastics Regulation entered into force until 2019, 97 applications for the authorisation of substances have been received for substances specifically to be used in plastic. This equates to approximately 12 dossiers per year and therefore between EUR 2.4 million and EUR 26.4 million per year on dossiers. On average, this equates to EUR 14.4 million per year. According to the SME Panel questionnaire100, the majority of SMEs do not have sufficient resources to apply for authorisation of a new substance in plastic FCMs. Not surprisingly, the SME panel questionnaire results show that the smaller the size of the enterprise, the lower the resources to prepare applications. A review of the EFSA register of questions shows that in the plastics sector, only a small fraction of all applications is submitted by SMEs - out of approximately 100 applications since 2011, only two (in 2018) have been identified to be submitted by SMEs. Establishing GMP and analytical testing account for the largest share of compliance costs for producers of plastic FCMs. The evaluation has estimated that these two cost elements account for 69% to 72% of overall costs. Within the scope of case study 3 (see annex 2), 16 companies provided detailed information on the costs linked to the FCM legislation and cost estimates for industry were based on these. Table 11 in annex 5 presents the costs per company and its size, differentiating between a minimum, average, and maximum amount. In total, estimates suggest annual costs of EUR 54 million to more than EUR 280 million for establishing GMP, and some EUR 93 million to almost EUR 350 million for analytical testing. As mentioned before, interviews with the industry suggest that the actual annual costs are likely to be close to the maximum estimated above, suggesting total costs close to EUR 630 million for industry per year. In the case of the FCM legislation, key administrative cost items are the cost for producing a DoC and SD. Companies employ between 0.1 and 6 full-time equivalents (FTEs)106 on administrative tasks linked to reporting requirements. The number depends on the size of the company. Table 12 in annex 5 reports on the minimum and maximum number of FTEs employed per company, broken down by company size. As for the compliance costs, numbers for small businesses had to be extrapolated based on information available for medium and large companies. Using a weighted average, these estimates can be translated into costs for companies. This suggests that administrative costs range between a minimum of EUR 3600 per year for a small company and a maximum of almost EUR 215 000 per year for a large company. This translates into total annual costs ranging between EUR 59 million and close to EUR 230 million. In relative terms, administrative costs stemming from FCM legislation account for less than 1% of turnover. They account for about a quarter of the overall costs of the FCM legislation for the plastics sector. According to the plastics industry (direct correspondence with the Commission), the duration of the process of risk assessment and moreover, risk management in the authorisation of substances leads to lost market time. This is significant given the investment it puts into dossiers. It points to long periods of time in particular in the inclusion of new monomers and additives in the Union list, which is often in contrast with the time taken to market substances on the US market. Non-plastic FCM industry The evaluation examined burdens to industry sectors not subject to specific harmonised EU measures to compare with the impact of EU-specific rules. Table 8 in annex 5 gives an overview of these costs compared with the plastics industry. Information was mostly available on compliance costs, which, like the plastics sector, appear to account for up to 2% of turnover for many sectors. However, depending on the sector concerned, there appears to be some variation, which is likely to reflect presence or absence of national requirements. For certain sectors, companies do not have to produce a DoC for their products or are not subject to specific testing requirements, which may reduce costs. On the other hand, resources spent on compliance costs for certain sectors including metals and alloys (5% of turnover), paper and board (4%) and printing inks (10%) are considerably higher. It was not possible to gather data to elaborate in detail on why these sectors’ costs are so high but are likely in part to relate to multiple national requirements, and three examples are given below. Additionally, industry confirmed that while certain costs are easily quantifiable (such as testing and dedicated human resources), other costs are unpredictable, making their assessment complicated. Such costs mainly relate to market and development opportunities that are missed in EU Member States’ markets with different national legislation, or when entering competition with harmonised materials (especially plastics). Rubber FCM industry According to national legislation, approximately the same number of substances are registered and used as for plastic (~900), which makes for a useful comparison. According to industry, diverging individual national approval schemes, containing a list of safety requirements and related tests to be applied to the final FCM article, increase costs. It argues that the lack of a homogeneous approval scheme and positive lists, in combination with the absence of mutual recognition across Member States, is also creating an unjustified burden for companies, most of which are SMEs. Costs for certifying product conformity or authorising the use of new substances are, according to them, multiplied for each country where products are commercialized. The cost for certifying a single product is at least EUR 5000. Whereas an inventory of existing “positive lists” of monomers and other compounding ingredients for rubber FCM from the Council of Europe Resolution on rubber products exists, it has not been implemented by most EU Member States, perhaps providing a lost opportunity for reducing costs. Using the example from table 13 in annex 5, zinc di(benzothiazol-2-yl) disulphide, the estimated costs from administrative preparation of the dossier for authorising the substance is EUR 60 000 in four Member States which equals EUR 240 000 compared with EUR 60 000 for one single dossier preparation at EU level. Therefore, the additional cost incurred is EUR 180 000. It is not known for any of these substances what additional costs may have incurred for different studies or data and testing requirements across the four Member States, and so the additional costs to the rubber industry may be significantly higher. FCM printing inks

Germany has recently prepared legislation to introduce a positive list for inks. In the accompanying impact assessment (page 90 onwards of the draft), it explores the effects and costs of the ordinance on authorities, as well as industry. It is estimated that the introduction of the ordinance would create costs of about EUR 18 million for the inks industry in Germany (EUR 900 000 per company) as one-off costs, with another EUR 2 million (EUR 100 000 per company) in ongoing or annual costs. Based on the input from the ink industry in Germany, authorisation processes can be expected to add another EUR 2 million per year. Costs for the whole value chain are estimated to be significantly higher, at about EUR 660 million one-off costs for the implementation of the ordinance. The impact assessment does not provide an estimate of the recurrent costs for the whole value chain nor the costs if printing inks would be regulated at EU level. Industry has argued that the legislation is disproportionate, increases barriers to the commercial success of innovation and drives up consumer prices, which is not supportive of on-going economic recovery. Safeguard measures on BPA The use of BPA in food and beverage cans is particularly significant, as the majority of cans (around 80%) utilise the BPA based epoxy-resin technology as a coating. Around 50 billion beverage cans and 20 billion food cans are produced in the EU each year; in the latter case, the estimated value of this market in 2010 was EUR 30 billion in the EU. Specific requirements laid down by the safeguard measures adopted by French legislation have had a knock-on impact throughout the EU and in wider Europe since production and distribution methods have been developed for the EU market as a whole. Costs derive not only from the research and development time of either replacement substances or alternative packaging materials, but also as a consequence of reformulation, testing, trial periods before marketing and questions over the effectiveness of replacements, leading to possible food waste and therefore additional costs. Overall costs to industry are high and in 2015, industry estimated such costs at up to EUR 1.5 billion. Burdens on SMEs Almost a third of SMEs report that costs linked to the FCM legislation are not proportionate to the size of companies, whereas a fifth of respondents to the SME survey100 state the opposite. Companies did not provide a reasoning for this judgement. However, there are certainly costs that are independent of the size of the business. The tests and evidence companies must produce is independent of the size of the company. As a result, these requirements can be particularly burdensome for smaller businesses. SMEs heavily rely on associations and service providers to get them the information they need as they do not have internal resources with knowledge of national systems across EU Member States. As discussed with industry representatives, the specific consequences for SMEs in monetary terms cannot be measured, but SMEs may not be able to understand or afford to meet the different requirements in national laws, which means they can be excluded from markets. The costs of additional testing are a burden, especially for small companies which cannot absorb such costs, or they simply have to decide where to sell in advance and test accordingly, which is restricting their access to the internal market. Case example 6 in annex 6 highlights some practical issues. Overall, costs to industry are estimated to be around 3% of the total turnover, with th