The EU Green Deal calls for the resolution of significant issues identified in the current assessment of food contact materials (FCMs), and a public consultation on this will end on 11 January 2023, with a committee decision due in the second quarter of 2023. These major issues relate to the absence of EU FCMs legislation and current EU rules.
The specifics are as follows:01 Inadequate functioning of the internal market and possible safety issues for non-plastic FCMs Most industries other than plastics lack specific EU rules, resulting in the lack of a defined level of safety and therefore no proper legal basis for the industry to work on compliance. While specific rules exist for certain materials at the national level, these often vary widely across member states or are outdated, creating unequal health protection for EU citizens and unnecessarily burdening businesses, such as multiple testing system. In other member states, there are no national rules because there are insufficient resources to act on their own. According to stakeholders, these issues also create problems for the functioning of the EU market. For example, FCMs of 100 billion euros per year, of which about two-thirds involve the production and use of non-plastic materials, including many small and medium-sized enterprises. 02 Positive Authorization List Approach Lack of focus on the final product The provision of a Positive Approval List for plastic FCM starting materials and ingredient requirements leads to extremely complex technical regulations, practical problems of implementation and management, and an excessive burden on public authorities and industry. The creation of the list created a significant obstacle to harmonizing the rules for other materials such as inks, rubbers and adhesives. Under current risk assessment capabilities and subsequent EU mandates, it would take approximately 500 years to assess all substances used in non-harmonised FCMs. Increasing scientific knowledge and understanding of FCMs also suggest that assessments limited to starting materials do not adequately address the safety of final products, including impurities and substances that are incidentally formed during production. There is also a lack of consideration of the actual potential use and longevity of the final product and the consequences of material aging. 03 Lack of prioritization and up-to-date assessment of the most hazardous substances The current FCM framework lacks a mechanism to rapidly consider new scientific information, for example, relevant data that might be available under the EU REACH regulation. There is also a lack of consistency in risk assessment work for the same or similar substance categories assessed by other agencies, such as the European Chemicals Agency (ECHA), thus the need to improve the “one substance, one assessment” approach. Furthermore, according to EFSA, risk assessments also need to be refined to improve protection of vulnerable groups, which supports the actions proposed in the Chemicals Strategy. 04 Insufficient exchange of safety and compliance information in the supply chain, the ability to ensure compliance is compromised. In addition to physical sampling and analysis, compliance documentation is critical to determining the safety of materials, and it details industry efforts to ensure the safety of FCMs. Security work. This exchange of information in the supply chain is also not sufficient and transparent enough to enable all businesses throughout the supply chain to ensure that the final product is safe for consumers, and to enable member states to check this with the current paper-based system. Therefore, more modern, simplified and more digitized systems compatible with evolving technology and IT standards will help to enhance accountability, information flow and compliance. 05 Enforcement of FCM regulations is often poor EU Member States have neither sufficient resources nor sufficient expertise to enforce current rules when it comes to implementing FCM regulations. The assessment of compliance documents requires specialized knowledge, and non-compliance found on this basis is difficult to defend in court. As a result, current enforcement relies heavily on analytical controls over migration restrictions. However, out of about 400 substances with migration restrictions, only about 20 are currently available with certified methods. 06 Regulations do not fully take into account the particularity of SMEs The current system is particularly problematic for SMEs. On the one hand, the detailed technical rules related to the business are too difficult for them to understand. On the other hand, the lack of specific rules means they have no basis for ensuring that non-plastic materials comply with regulations, or do not have the resources to deal with multiple rules in member states, thus limiting the extent to which their products can be marketed across the EU. In addition, SMEs often do not have the resources to apply for substances to be assessed for approval and must therefore rely on applications established by larger industry players. 07 Regulation does not encourage the development of safer, more sustainable alternatives Current food safety management legislation provides little or no basis for developing rules that support and encourage sustainable packaging alternatives or ensure the safety of these alternatives. Many legacy materials and substances are approved based on less rigorous risk assessments, while new materials and substances are subject to increased scrutiny. 08 The scope of control is not clearly defined and needs to be re-examined. Although the current 1935/2004 regulations stipulate subject matter, according to the public consultation conducted during the evaluation period, about half of the respondents who commented on this issue stated that they were It is particularly difficult to fall within the scope of the current FCM legislation. For example do plastic tablecloths require a declaration of compliance.
The overall goal of the new initiative is to create a comprehensive, future-proof and enforceable FCM regulatory system at EU level that adequately ensures food safety and public health, guarantees the efficient functioning of the internal market, and promotes sustainability. Its goal is to create equal rules for all businesses and support their ability to ensure the safety of final materials and items. The new initiative fulfills the Chemicals Strategy’s commitment to ban the presence of the most hazardous chemicals and strengthen measures that take into account chemical combinations. Given the goals of the Circular Economy Action Plan (CEAP), it supports the use of sustainable packaging solutions, promotes innovation in safer, environmentally friendly, reusable and recyclable materials, and helps reduce food waste. The initiative will also empower EU member states to effectively enforce the resulting rules. The rules will also apply to FCMs imported from third countries and placed on the EU market.
background The integrity and safety of the food contact material (FCMs) supply chain is critical, but some chemicals can migrate from FCMs into food, resulting in consumer exposure to these substances. Therefore, in order to protect consumers, European Union (EC) No 1935/2004 establishes basic EU rules for all FCMs, the purpose of which is to ensure a high degree of protection of human health, protect the interests of consumers and ensure the efficient functioning of the internal market. The ordinance requires the production of FCMs so that the chemicals are not transferred into food products that endanger human health, and sets out other rules, such as those on labelling and traceability. It also allows the introduction of specific rules for specific materials and establishes a process for the risk assessment of substances by the European Food Safety Authority (EFSA) and eventual authorization by the Commission. This has been implemented on plastic FCMs for which ingredient requirements and lists of approved substances have been established, as well as certain restrictions such as migration restrictions. For many other materials, such as paper and cardboard, metal and glass materials, adhesives, coatings, silicones and rubber, there are no specific rules at EU level, only some national legislation. The basic provisions of current EU legislation were proposed in 1976 but have only recently been assessed. Experience with legislative implementation, feedback from stakeholders, and evidence gathered through the ongoing assessment of FCM legislation suggests that some of the issues are related to the lack of specific EU rules, which has led to uncertainty about the safety of some FCMs and internal market concerns. Further specific EU legislation is supported by all stakeholders including EU Member States, the European Parliament, industry and NGOs.
Post time: Oct-28-2022