Evaluation of EU Rules

All information related to the evaluation of food contact materials (FCMs) is published on this page. It provides context to the evaluation, its purpose and scope and the main questions answered.

All relevant documents are published below. These can be found under 'consultation activities and outputs' including the synopsis report and under 'final reports and other relevant information' including the final report of the study to support the evaluation, as well as other relevant Commission reports. The Staff Working Document, which will be produced by the Commission taking into account all available information, is published below.

The information collected from the evaluation supports a need to revise the EU rules on FCMs. The Commission has made a commitment to do so under the Farm to Fork Strategy. The revision will be accompanied by an impact assessment, providing the opportunity to gather further information needed to address information gaps identified during the evaluation and to support the revision work. Further information on the revision is published here.

The first Directive 76/893/EEC on food contact materials (FCMs) applicable in the EU was introduced in 1976 and rules on FCMs have been in place ever since. Currently, Regulation (EC) No 1935/2004 of the European Parliament and of the Council provides a harmonised legal EU framework for FCMs. It sets out the general principles of chemical safety and inertness for all FCMs in relation to human health, providing further powers to enact specific EU measures for specified materials and articles. It lays down the procedure to perform safety assessments of substances used to manufacture FCMs as well as rules on labelling, compliance documentation and on traceability. Further information on the general and specific EU FCM legislation can be found on the FCM legislation page.

Since the inception of its basic provisions set out over 40 years ago, the EU legislation on FCMs has never been evaluated. Additionally, and on the basis of evidence gathered so far, it appears that several fundamental issues are present in the existing approach to regulating FCMs at EU level. This includes the listing of authorised substances, risk assessment and risk management approaches; information flow and compliance in the supply chain; enforcement as well as coherence with other EU legislation. Furthermore, the lack of EU specific rules beyond plastic FCMs is considered by many stakeholders to negatively impact the correct functioning of the internal market and moreover the possible safety of FCMs.

On the basis of these perceptions and the evidence that already exists, which indicates a need for greater coherence and simplification, as well as the lack of any evaluation since the introduction of EU rules on FCMs, it is considered necessary to evaluate how the current Regulation has performed in relation to its original objectives.

The overall purpose of this evaluation is to assess to what extent the current EU legislative framework for FCMs is fit for purpose and delivers as expected. The process will cover the main five evaluation criteria, namely:

• Effectiveness of the approaches, processes and tools set up by the FCM Regulation and its associated and implementing measures in relation to the original objectives of the Regulation;
• Efficiency of the approaches, processes and tools set up by the FCM Regulation and its associated and implementing measures in relation to the resources used;
• Relevance of the Regulation in relation to current scientific and technological developments in the field of FCMs, and stakeholders' needs and expectations;
• Coherence internally and with other related interventions at National, European and International level;
• EU added value compared to what could have been achieved by Member States or otherwise without regulating FCMs at EU level.

The scope of the evaluation includes the basic requirements, the implementation and the functioning of Regulation (EC) No 1935/2004 from its entry into force on 23 November 2004 and the period concerning the general rules that have been maintained since the introduction of the first FCM legislation in 1976.

It includes the concepts and ways in which subsequent implementing measures regulate FCMs, including risk assessment and risk management processes, authorised lists of substances, document requirements, Good Manufacturing Practices (GMP), traceability and enforcement. However, it does not cover the detailed rules set out in the specific measures, for example whether a particular substance should be authorised or not, specific restrictions or testing methodologies.

It also considers the situation concerning FCMs for which no specific EU measures exist but may exist at national level.

The aim of the evaluation is to provide a basis on which the Commission can take further steps to consider what, if any, possible steps need to be taken in the future concerning the regulation of FCM in the EU, for example printed-FCMs.

In order to carry out the evaluation, 10 questions have been prepared covering the five evaluation criteria:

Effectiveness

1. To what extent has Regulation (EC) No 1935/2004 and subsequent implementation achieved its objective of providing the basis for securing a high level of protection of human health and the interests of consumers in relation to FCM?
2. To what extent has Regulation (EC) No 1935/2004 and subsequent implementation ensured the effective functioning of the internal market in relation to the placing on the market in the EU of FCMs?

Efficiency

1. What are the quantifiable benefits, taking into account resources (cost, time, etc.) to stakeholders, including:
   1. Consumers (e.g. health and safety benefits);
   2. Business operators, including specifically for SMEs and microbusinesses (e.g. in demonstrating compliance, market access);
   3. Member States' Competent Authorities (e.g. in ensuring safety and control of FCMs)?
2. 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?
3. Taking into account the answers to questions 3 and 4, how efficient is Regulation (EC) No 1935/2004 and its implementation tools in ensuring the safety of FCMs?

Relevance

1. What are the needs, interests and expectations of the following stakeholders and to what extent does the current legislation address them:
   1. Consumers and their representative organisations?
   2. Business operators including food business operators? and;
   3. Member States' Competent Authorities?
2. To what extent has Regulation (EC) No 1935/2004 and its subsequent implementation allowed for evolving science, prioritisation and innovation?

Coherence

1. To what extent is Regulation (EC) No 1935/2004 internally coherent, including all of its implementing acts?
2. To what extent are Regulation (EC) No 1935/2004 and its subsequent implementation including the risk assessment and risk management approaches taken, externally coherent with other relevant legislation and policies?

EU added value

1. What is the EU added value of Regulation (EC) No 1935/2004 in relation to its main objectives?

Stakeholder participation throughout the entire process is essential for the success of the evaluation.

The consultation process aims to engage all relevant stakeholders and to collect evidence on the functioning and application of Regulation (EC) No 1935/2004 and its associated implementing measures. Consultation activities have been seeking stakeholders' experiences and views on the scope and the approaches set in the Regulation, as well as to identify any positive or negative effects, including unexpected impacts, and any emerging issues as a consequence of the current legislation. Consultation activities are designed to provide evidence to the Commission in answering the evaluation questions.

An overview of the main categories of stakeholders is provided in the table below. The consultation process includes a strong representation of scientific and technical expertise from both public and private sectors as well as adequate representation from consumer and civil society organisations, including NGOs. Care is taken to adequately select and reach business operators along the whole supply chain of FCMs, including their representatives, with particular attention to Small and Medium Enterprises (SMEs) and micro enterprises. National authorities, other EU institutions and supra-national bodies are included. Those involved in consultancy, legal affairs and communication should also be participating.

The different steps of the consultation process and strategy require different types of consultation activities. Depending on the stakeholder group identified, different tools and methods will be used in order to conduct the consultation.

During a 4-week period 28 November – 26 December 2017, all interested stakeholders were able to provide feedback on the FCM Evaluation Roadmap. This was the first step of the consultation in order to receive feedback on the general consultation approach to the evaluation. A total of 26 stakeholders responded, including business organisations and NGOs.

The consultation period was launched in September 2018 with a stakeholder workshop and the open public consultation for the evaluation followed on 11 February 2019. This consultation exercise was made available in all official EU languages, aimed at capturing opinions and views of the general public including consumers in order to answer the evaluation questions.

Further consultation activities have included a second workshop, targeted interviews, focus groups, case studies, discussions within the context of the Member States' Expert Working Group on Food Contact Materials and an SME Panel questionnaire, aimed specifically at small and medium-sized businesses.

A table summarising the consultation activities and outcomes can be found below.

The following reports and documents support the final outcome of the evaluation and drafting of the Staff Working Document.

In addition to these published studies, further information has been gathered to inform the evaluation.

Recent work undertaken by the Commission on other sectorial or horizontal legislation also indicates possible issues with the current FCM legislation. For example, the Fitness Check on General Food Law identifies shortcomings in authorisation procedures foreseen in other secondary legislation e.g. FCMs other than plastics. The Single Market Strategy cites the need to strengthen the single market for goods and improve the Mutual Recognition principle on which FCMs rely. Furthermore, the study to support the Fitness Check on the most relevant chemicals legislation (“Fitness Check +”) highlights issues on coherence of data, science, and risk management procedures and measures, between different regulatory areas including those relating to FCMs.

The EU's risk assessment body for FCMs, the European Food Safety Agency (EFSA) has published an opinion on developments in risk assessment. This opinion examines the safety assessment of chemicals in food and impact on evaluating FCMs, concluding that more focus is needed on the finished materials and articles as well as non-intentionally added substances (NIAS) generated through the manufacture of FCMs and on vulnerable groups. EFSA has also undertaken work concerning assessment of FCMs for which there is no harmonised approach at EU level. This includes the Report of the EFSA's Scientific Cooperation Group (ESCO) on non-plastics, which highlighted that only 230 substances used in non-plastic FCMs have been risk assessed at national level since publication of SCF Guidelines in 1991. Further, work carried out through EFSA's network on Food, Ingredients and Packaging (FIP network) is attempting to bridge current knowledge gaps on the risk assessment of non-plastic FCMs.