On December 18, 2020, the European Commission’s (EC) Directorate General for Health and Food Safety (DG SANTE) opened a consultation on its inception impact assessment (IIA, which is essentially an extended roadmap) for the ongoing evaluation and revision of EU legislation on food contact materials (FCMs). The consultation is open until January 29, 2021. DG SANTE is set to host a webinar to present the roadmap on January 20, 2021.
In the published IIA document, which can be downloaded from the consultation’s webpage, DG SANTE summarizes that “the basic provisions of the present EU [FCM] legislation were introduced in 1976 but until recently had never been evaluated.” Therefore, in 2018 the ongoing Evaluation of FCM policy legislation was initiated, starting with a first stakeholder workshop (FPF reported), which was followed by a public consultation (FPF reported) and a second stakeholder workshop (FPF reported). This still-ongoing evaluation covers both the general FCM framework Regulation (EC) No 1935/2004 as well as several more specific FCM-relevant legislation pieces, such as Regulation (EC) No 10/2011 on plastic FCMs. The evidence and feedback collected by the EC so far have confirmed the existence of “problems that are linked to the absence of specific EU rules, which leads to uncertainty about safety of some FCMs and internal market problems.” Broad support for the need to introduce “further specific EU legislation” was expressed “by all stakeholders including EU Member States, the European Parliament, industry, and non-governmental organizations.” In addition, “several [other] fundamental issues present in the existing approach” were revealed.
Problems intended to be tackled through revising the EU’s FCM legislation
The IIA outlines the following 8 “fundamental issues,” which “relate both to the absence of EU specific measures (1) as well as various aspects of the current EU rules (2-8) as follows”:
1. “Lack of functioning of the internal market and possible safety issues for non-plastics FCMs.” The absence of harmonized EU rules for most FCM types results in “a lack of a defined level of safety and consequently no appropriate legal basis for industry to carry out compliance work.” In addition, difficulties with enforcement and control of imports are highlighted as accompanying challenges.
2. “The positive authorized list approach and lack of focus on the final article.” While some stakeholders view positive authorized lists as “advantageous,” it is also recognized that the use of positive lists can “bring practical problems and limitations” and result in “excessive burdens for public authorities and industry alike.” For example, “the creation of lists causes a significant obstacle to harmonization of rules for other materials such as inks, rubbers and adhesives.” An additional burden comes from the need to “re-evaluate certain substances when new scientific information becomes available.” Furthermore, current FCM assessments which are focused on the starting substances “do not sufficiently address the safety of the final product” and also do not consider “the actual potential use and lifespan of the final article and consequences of the aging of the material.” This approach “puts a disproportionate emphasis on starting substances, leaving the safety of the final material for the supply chain to resolve without clear rules,” DG SANTE concludes.
3. “Lack of prioritization of the most hazardous substances and up-to-date assessments.” It is noted that “the current EU legislative approach does not consistently prioritize the most hazardous substances in all FCMs” and there is also no mechanism “to swiftly take into account new scientific information” and results of substance assessments carried under other legislations (FPF reported). To address this, the EU’s new Chemicals Strategy “gives a clear commitment to take a more generic approach to regulating FCM substances whose properties give rise to the greatest concern, such as carcinogenic, mutagenic and reprotoxic substances (CMRs), those that act as an endocrine disruptor (ED) and those that are persistent and bioaccumulative (PBTs and vPvBs).” In addition, it needs to be assessed if this approach should be extended “to other chemicals with specific harmful properties.” Overall, there is a clear need for an “improved ‘one substance, one assessment’ approach.”
4. “Exchange of safety and compliance information in the supply chain is poor and the ability to ensure compliance is compromised.” It is emphasized that both the “physical sampling and analysis” and “compliance documentation” are “crucial” for establishing FCM safety. However, the exchange of information across the supply chain is currently “insufficient and not transparent enough.” Here, “integration of a more modern, simplified and digitalized system” into the legislation is seen as possible means “to improve accountability, information flow and compliance work.”
5. “Enforcement of rules on FCMs is generally poor.” EU Member States currently encounter “difficulties . . . in enforcing FCM rules,” which relate “to both the lack of clear rules for non-plastic materials and the requirement to control the current EU specific rules, which are too technical, burdensome and challenging.” For example, “accredited methods are currently available for approximately only 20 substances out of around 400 for which there is a migration limit.” Overall, “controls on FCMs are not a high-priority for Member States,” and this “leaves a gap in the regulation and enforcement of many FCMs on the market,” DG SANTE concludes. “To some extent,” however, “this gap is filled by large food business operators with enough purchasing power to force their suppliers to comply with their requirements.”
6. “Rules do not sufficiently take into account the specificity of SMEs.” Small and medium enterprises (SMEs) in particular are highly challenged by the existing FCM regulation system, because they do not have enough resources to ensure compliance with multiple non-harmonized rules and “are therefore restricted as regards the extent to which they can market their products across the EU.”
7. “Rules do not encourage development of safer and more sustainable alternatives.” The existing EU FCM regulation “provides little or no basis on which to develop rules that support and encourage sustainable alternatives to packaging or ensure these alternatives are safe,” DG SANTE states. Furthermore, the current system “de-incentivizes innovation” because “many legacy materials and substances were authorized based on a less stringent risk assessment, while new materials and substances are subject to a steadily increasing level of scrutiny.” The revised FCM legislation also needs to address “recyclability of all materials and new technologies such as chemical recycling . . . in order for the EU to reach its ambitious recycling objectives,” DG SANTE observes.
8. “The subject matter is not always clear and definitions need to be reviewed.” DG SANTE informs that “difficulties in determining whether certain products fall under the scope of the present FCM legislation” were mentioned by “around half of consultees” who provided feedback on the previous public consultation. These issues are partially stemming “from the challenges of predicting or monitoring consumer behavior and use of certain articles.” For example, it is not clear if a Declaration of Compliance is needed for plastic tablecloths. There are also further unclarities with regard to “FCMs that are regulated under other pieces of legislation, for example medical feeding tubes.”
Basis for EU intervention
The eight problem areas identified above justify the need for EU-level intervention “on grounds of subsidiarity and added-value,” since the current system was found to “(1) create different levels of safety for consumers, some of which may not be sufficient and (2) hinder the free movement of goods and create unequal and unfair competition,” and therefore the EU “can take action to achieve functioning of the internal market, including rules relating to health and safety, the environment and consumer protection.”
Objectives and policy options
The IIA summarizes that “the overall objective of the new initiative is to build a comprehensive, future-proof and enforceable regulatory system for FCMs at EU level that fully ensures food safety and public health, guarantees effective functioning of the internal market and promotes sustainability.” It also aims to create “equal rules for all businesses” and support them “in their ability to ensure safety of the final materials and articles.”
DG SANTE informs that “a range of different possible [policy] measures is [currently] under consideration,” and these possible measures “will be evaluated and further consolidated as part of the full impact assessment” after receiving stakeholder feedback. The current discussion focuses on two broadly defined groups of possible measures “that cover all eight of the specific issues identified.”
The first group includes measures that aim to “ensure the safety and sustainability of the final FCM” and thus principally concerns “problems 1, 2, 3, 7 and 8”; it is further divided into three subgroups (A-C) described below. The measures assigned to the second group aim to “ensure exchange of information in the supply chain, support for SMEs and enforcement of the rules” and thus principally concern “problems 1, 4, 5 and 6”; this group is further divided into two subgroups (D and E).
A. “Shifting the focus onto final materials.” This option foresees the creation of “new EU specific rules which would refocus on the safety of the final material and/or combinations of materials, addressing their full characteristics and therefore all substances that may potentially migrate into food, instead of only starting substances.” The “level of safety that needs to be achieved” will be legally defined, and “clear rules on how to achieve this” will be set as well. This could be supported by strengthening and further developing rules on Good Manufacturing Practices (GMP). In addition, “industry would be required to determine how the goals would be achieved and implement self-regulation guidelines, customized for each of the concerned sectors.”
B. “Prioritizing the assessment and management of substances.” DG SANTE maintains that “the assessment of individual substances or groups . . . would still remain a key component of the overall safety evaluation and risk management options,” but “a tiered approach would be used to prioritize regulation of substances, according to a number of factors including their identified hazard properties, together with their use, migration potential and eventual exposure.” A greater emphasis would be put on protecting sensitive populations such as pregnant women and children, and on ensuring that “risk assessments take account of the most up-to-date available scientific information and are updated and revised appropriately and in a timely manner.” The respective roles of the European Chemicals Agency (ECHA) and European Food Safety Authority (EFSA) will be further clarified to support the ‘one substance, one assessment’ approach. The “Tier 1 substances,” including CMRs, EDs, and PBT/vPvBs, will be assessed and managed via a “generic approach” which should consider “the essential uses of substances in FCMs.” The “Tier 2 substances,” defined as “substances with other properties of specific concern such as those in nano-form or those migrating in high amounts,” would require “a safety assessment using available expertise from EU risk assessment bodies.” The “Tier 3 substances” are defined as “substances that are more benign and migrate in low amounts.” To manage these substances, “an approach to support and guide business operators in their risk assessment would be developed.”
C. “Supporting safer and more sustainable alternatives.” Here, the EC foresees introducing “specific rules to ensure that FCMs manufactured from less traditional and potentially more sustainable production sources and methods, such as those using plant or bio-based technology, are subject to dedicated and clear rules on safety to incentivize their use.” In addition, the EC would “expand rules to prioritize and support all forms of safe re-use and recycling, to exclude risks from contamination and to include all recycling technologies,” with the goal to “ensure consistency and coherence with legislation designed to protect the environment.”
D. “Improving quality and accessibility of supply chain information for compliance and enforcement.” For this objective, the EC “would introduce clear and consistent rules on data requirements and information transfer throughout the supply chain, including a Declaration of Compliance for all FCMs.” The information system would be “fully digitalized” to make it easier both for businesses and for enforcement authorities.
E. “System for ensuring compliance of the final FCM.” Here, the initiative proposes to “look at the possibility of making use in this area of delegated bodies . . . and /or of notified bodies tasked with conformity assessment.” This system “would be complementary, allowing Member States to maintain overall control of enforcement.” In addition, “further development of technical standards,” e.g. by the EU Reference Laboratories, will be explored.
Options to be evaluated in the impact assessment
During the planned impact assessment, “two fundamental options will be further evaluated . . . using the baseline situation as a benchmark,” and the focus will be on the “feasibility of the envisaged options” (that is, options A-E above) as well as on the “extent to which they solve the issues identified” (that is, issues 1-8 above). The baseline situation is defined as a “continuation of the current implementation of the existing rules” on the EU-wide and national levels. The two options include:
Option 1: “Use the current regulatory framework (with Regulation (EC) No 1935/2004 as a cornerstone)”
Option 2: “Develop a new regulatory framework, replacing the current Regulation.”
Further sub-options “may be developed when performing the impact assessment.”
Impact assessment and further consultation activities
The initiative to revise the EU FCM regulations “represents a major legislative proposal” expected to have a “significant impact,” thus requiring the performance of an impact assessment where all possible options and their likely impacts should be evaluated. The outlined types of “likely impacts” include:
- likely economic impacts, e.g., decreased health costs due to higher consumer protection; improved competitiveness of SMEs and increased innovation due to simplification of rules; increased costs caused by the introduction of additional harmonization measures, which are nonetheless expected to pay out in the long term; increased global competitiveness of EU businesses and “growth in materials that support sustainability.”
- Likely social impacts, including improved health and well-being, facilitation of consumer choices, reduction of food waste, and increased “production of more sustainable materials.”
- Likely environmental impacts, where a contribution “to the circular economy, plastics strategy and non-toxic environment” is expected and “reduction of waste and support for the use of materials including polymers that can be easily recycled and safely used again as food contact materials will be considered.”
- Likely impacts on fundamental rights, e.g. potential issues with personal data protection arising from digitalization of the system.
- Likely impacts on simplification and/or administrative burden, where a reduced burden is expected due to the emergence of “one set of simplified EU rules to follow,” as well as increased digitalization.
The impact assessment will “run in parallel” with the evaluation process, which is still ongoing. It will benefit from already published studies, such as diverse fitness checks, the European Parliament’s report on FCMs, or the “baseline” study on non-harmonized FCM measures (FPF reported). However, more data are needed still, “in particular to compare the possible benefits such as effectiveness and efficiency of new EU rules compared with the current baseline.” Therefore, “further study work” will be performed “in consultation with relevant stakeholders, including Member States, business operators and consumer organizations.” Further consultation activities are foreseen, including a “12-week internet based public consultation” provisionally planned for the second quarter of 2021; a set of targeted consultation activities and interviews, tailored at specific stakeholders; and “stakeholder working groups . . . to complement the process, gather views on possible future legislation and ensure that all relevant interested parties are included.”
Significance for other EU policies
DG SANTE notes that “legislation on FCMs is directly relevant for the success of key Commission policies under the EU Green Deal“ (FPF reported), and therefore the recently published Farm to Fork Strategy committed “to revise the FCM legislation in order to improve food safety and public health” (FPF reported). Revision of FCM regulations is also crucial to the EU’s Circular Economy Action Plan (CEAP) with its follow-up Plastics Strategy published in 2018 (FPF reported), which strives “to ensure packaging is re-usable and recyclable.” FCM policy revisions also “contribute to the ambitions of the Chemical Strategy for Sustainability towards a toxic free environment” (FPF reported). Lastly, the COVID-19 pandemic has also “highlighted the importance of FCMs in safeguarding food supply chains and ensuring EU food security in times of crisis” (see FPF resources page).
Stakeholder responses to the IIA consultation are being accepted until January 29, 2021.
The National Law Review (April 21, 2021). “The Status of EU Food Contact Materials.”
Stefan Scheuer (January 8, 2021). “European Commission takes first step towards toxic-free food packaging.”
EC (December 18, 2020). “Revision of EU rules on food contact materials.”
Chemical Watch (December 22, 2020). “European Commission eyes priority tier system for FCM chemicals.”
Katy Askew (January 13, 2020). “EC kicks off food contact material revision: ‘Public health has been inadequately protected from toxic chemicals for too long’” FoodNavigator