Compliance: adherence to written rules

An FCM is considered compliant when it passes the tests required by legislation.
For example, for plastics, Regulation (EU) No. 10/2011 sets out global and specific migration limits that must be respected. If analyses show values below the limits, the material is compliant.
Compliance, therefore, is a “legal” concept: the product meets the parameters established by law.

Safety: the actual protection of the consumer

But compliance alone is not sufficient to guarantee safety.
According to Article 3 of Regulation (EC) No. 1935/2004, an FCM is truly safe only if it does not release substances in quantities that:

• could endanger human health,
• cause a change in the composition of the food,
• alter in an unacceptable way the organoleptic characteristics of food (taste, smell or appearance).

In other words, safety is a broader concept than compliance: it concerns the actual effects that the material may have on food and, therefore, on the consumer.

Some practical examples:

• A plastic cup may show global migration values below the legal limits → compliant. However, it could release unregulated compounds that are toxicologically relevant → not safe.
• A metal container may comply with the migration limits for metals → compliant. But if it alters the taste of the food → not safe.
• A stainless-steel cutlery item that does not release hazardous substances and complies with all the analytical limits set by law → compliant and safe.

These examples show that compliance is a necessary but not sufficient condition.

Conclusions

The real protection of the consumer cannot be achieved by limiting the assessment to the analytical verification of legal limits. A more comprehensive approach is required, which includes:

• knowledge of the raw materials used and of manufacturing and processing methods,
• consideration of real conditions of use (temperature, contact time, type of food and packaging processes),
• updated toxicological and organoleptic risk assessments.

In summary:

• an FCM may be safe but not compliant if it contains non-authorized substances which, however, pose no toxicological risk;
• an FCM may be compliant but not safe if, while meeting the legal parameters, it releases undesirable substances or significantly alters the organoleptic characteristics of food.

The distinction between compliance and safety therefore lies in the difference between the formal respect of regulatory requirements and the substantive guarantee of consumer health protection (respect of art. 3 – Regulation EC 1935/2004). In this perspective, it is necessary to move from a “target” analytical approach to a risk assessment approach, integrating experimental data with expert critical evaluation and with adequate knowledge of the production chain.
Consumer protection is therefore achieved through a control system that goes beyond the verification of analytical requirements and is based on a critical analysis of data, structured dialogue with the raw material suppliers, and, where possible, with the end-users.

Regulatory framework

• FCMs (Food contact materials) are regulated at the European level by Regulation (EC) No. 1935/2004, also called the FCM Framework Regulation, which sets out the general principles.
• For certain categories of materials (e.g., plastics under Reg. (EU) 10/2011), there are specific harmonized regulations that establish migration limits and other technical requirements.
• In Italy, some decrees supplement these provisions for various types of non-harmonized materials: paper, glass, rubber, stainless steel, aluminium, etc.

What is mandatory

Every business operator must ensure that their FCMs comply with the legislation.
The main obligation is to draft and make available a Declaration of Compliance (DoC), based on adequate supporting documentation:

• traceability and proper documentation of raw materials,
• test results demonstrating compliance with specific rules,
• toxicological and organoleptic evaluations,
• adherence to GMP (Good Manufacturing Practices, Reg. (EC) 2023/2006) with controlled production procedures to ensure material safety.

“FCM Certification”: why are we talking about it?

• Some certification bodies issue voluntary certificates or attestations, primarily based on audits and laboratory tests, demonstrating compliance with regulatory requirements.
• These are not mandatory certifications nor unique at the EU level: they have commercial value and serve as guarantees for customers, not as legal proof.
• Sometimes the term “FCM certification” is used incorrectly; in reality, these are compliance attestations or voluntary certifications related to management systems (e.g., ISO 22000, BRC Packaging, etc.) that include FCMs.

Conclusions

To ensure FCM safety and regulatory compliance:

• There is no official and mandatory “FCM certification”. Compliance with regulatory requirements is demonstrated through a mandatory document, the Declaration of Compliance.
• For FCM manufacturers and distributors, the concrete obligations are to ensure material safety through:
  • drafting and making available the Declaration of Compliance (DoC),
  • conducting specific tests and toxicological evaluations,
  • ensuring traceability of raw materials,
  • adopting GMP throughout the production process.
• Voluntary certifications exist and can, in some cases, enhance reliability toward customers and markets.

Operators in the FCM sector should focus on regulatory compliance, safety and traceability, while any voluntary certifications serve as additional guarantees.

Context of Single-Use Plastic Restrictions

In recent years, the UK has taken increasingly stringent measures to tackle plastic pollution, with a particular focus on single-use products. Restrictions such as bans on the sale of certain single-use plastic products, such as straws, cutlery, plates, and measures that increase the cost of single-use plastic products for consumers and producers have been introduced in order to incentivise the use of sustainable alternatives and protect the environment.

In the report, the OIM analyses how these policies, which vary between the UK nations (England, Scotland, Wales and Northern Ireland), can have a negative impact on the internal market. While the intent of these policies is positive for the environment, differences in national laws could disrupt trade, complicating the landscape for companies and increasing costs.

National Inequalities and Challenges for Companies

One of the key findings of the report is the inequalities in single-use plastics policies across the UK. While England and Scotland have adopted strong policies to reduce the use of single-use plastics, Wales and Northern Ireland have been slower to implement such measures.

This disparity creates challenges for companies operating in multiple jurisdictions, which face different regulations that impact the production and distribution of products. Companies must adapt their products to local laws, which leads to additional costs and logistical challenges. Furthermore, the report highlights that this fragmentation of policies can create distortions in the market, favouring some areas over others and damaging the competitiveness of companies operating nationally.

Internal Market Implications

Another important aspect of the report is its focus on the functioning of the UK’s internal market. Divergent regulations risk undermining the fundamental principle of free movement of goods within the UK, enshrined in the Internal Market Act 2020. This act is designed to ensure that national laws and policies do not harm trade between UK nations.

According to the report, if national laws continue to differ significantly, companies could face higher costs and increased administrative complexity, reducing economic efficiency. Companies could also be discouraged from expanding their business at national level if differing regulations between nations create barriers to trade.

OIM’s Recommendations

To address these issues, the OIM made some key recommendations:

1. Harmonisation of policies: One of the main proposals concerns the harmonisation of regulations on single-use plastics between the different nations of the UK. The OIM suggests that a more coordinated approach could reduce trade barriers and make the internal market more efficient.
2. Intergovernmental cooperation: The report encourages greater cooperation between national governments to ensure that environmental policies are implemented effectively, without hindering trade and business competitiveness.
3. Evaluation of existing policies: The OIM suggests continuously monitoring and evaluating the impact of SUP policies to ensure that green objectives are achieved without compromising the efficiency of the internal market.

Conclusions: Balancing the Environment and the Economy

In summary, the report highlights the importance of balancing environmental needs with the economic needs of the UK. Restrictions on single-use plastics are essential to reduce environmental pollution and promote sustainable alternatives. However, it is equally important that these regulations are implemented in a way that does not damage the UK internal market and does not hinder the competitiveness of businesses.

The OIM therefore proposes a more coordinated approach that allows environmental objectives to be achieved without compromising the effectiveness of the internal market. Only through greater cooperation and harmonisation of policies between regions can the UK ensure an effective ecological transition, which benefits both the environment and the national economy.

Sustainable Design and Packaging

The regulation aims to promote more eco-friendly product design, focusing on criteria that reduce environmental impact, such as limiting hazardous substances, optimising energy efficiency and increasing recyclability.

For packaging, this means choosing materials that can be easily reused or recycled, reducing the volume of waste and improving the circularity of the material.

Digital Product Passport

A key element of the regulation is the introduction of the Digital Product Passport (DPP), a tool that provides transparent and detailed information on the life cycle of a product, including its eco-friendly characteristics, waste management and overall sustainability. This digital passport is designed to support consumers, authorities and businesses in assessing the environmental impact of products and to facilitate traceability throughout the supply chain.

Ban on Destruction of Unsold Goods

The regulation also includes a ban on the destruction of unsold goods, a measure that contributes to the fight against waste and promotes greater responsibility in business practices. The idea is to encourage reuse, recycling or other end-of-life management of products, reducing the need to dispose of unused items in landfill or through physical destruction.

Link to PPWR

The Packaging and Packaging Waste Regulation (PPWR) focuses on the management of packaging and packaging waste, setting targets for circularity and reducing the environmental impact of packaging. The relationship between Regulation 2024/1781 and the PPWR is crucial, as the former establishes design criteria to reduce the use of hazardous substances and foster sustainability, while the latter specifically addresses the management of packaging and packaging waste. The presence of Substances of Concern (SoC), such as heavy metals and other hazardous chemicals, is a key element in both regulations. The reduction of these substances is a key objective to improve the sustainability of packaging and foster material circularity.

Substances of Concern

SoCs are defined in PPWR as those substances that meet certain hazard criteria, for example, substances that are toxic, persistent in the environment or that may have an adverse effect on human health. Regulation 2024/1781 requires that packaging is designed to minimise the inclusion of these substances, both in the packaging materials themselves and in other components. This could involve, for example, the elimination of heavy metals such as lead, cadmium or mercury, which are harmful to both the environment and health.

ESPR Implementation Timelines and Phases

The implementation of the Ecodesign Regulation will follow a gradual process, with deadlines for the introduction of new rules that promote environmental sustainability in product design and production. The main phases are:

1. Establishment of the Ecodesign Forum (Group of Experts on Ecodesign for Sustainable Products and Energy Labelling) at the end of 2024: Reference point for dialogue between the various stakeholders, aimed at defining the guidelines for ecodesign.
2. Adoption of the first work plan (by 19 April 2025): Definition of the concrete actions and priorities of the regulation in relation to sustainability.
3. Publication of the Delegated Acts on the prohibition of destruction of unsold goods and exemptions (Q2 2025): Important measures for sectors such as textiles and electronics, to reduce the waste of still usable goods.
4. Publication of Delegated Acts on the Digital Product Passport (DPP) (by the end of 2025): Introduction of an innovative tool to monitor the environmental characteristics of products.
5. Adoption of the first ESPR measures (2026): Measures to regulate product design, with the introduction of specific obligations.
6. Entry into force of the first product requirements (2027/2028): Manufacturers will have to comply with new ecodesign requirements that include sustainability and environmental impact reduction obligations.

The delegated acts will establish the design characteristics necessary to ensure the environmental sustainability of products, including new information and performance specifications, the introduction of the DPP, the ban on the destruction of unsold goods and the strengthening of customs controls and market surveillance. The first delegated act will enter into force no earlier than 19 July 2025, giving companies time to adapt to the new obligations.

In conclusion, Regulation 2024/1781 aims to promote a synergy between product sustainability and eco-friendly management of packaging, with the aim of reducing environmental impact, optimising the circularity of resources and encouraging responsible design and production practices.

EFSA has recently carried out a new assessment of the public health risks of styrene, a substance used in plastic FCM, currently regulated in Regulation (EU) 10/2011 on plastics without a specific migration limit (SML) or other use restrictions.
In 2019, the International Agency for Research on Cancer (IARC) published a monograph classifying styrene and its main metabolite, styrene-7,8-oxide (SO), as “probably carcinogenic to humans”. As this classification could influence the inclusion of styrene in the Plastics Regulation, the European Commission asked EFSA to assess whether the evidence presented by IARC could impact the safety of using styrene in food contact materials.

In September 2020 EFSA, with a first assessment, concluded that concerns about the genotoxicity of styrene following oral exposure could not be excluded and that further data were needed to accurately assess its safety in FCM.
Considering the uncertainty about genotoxicity, the absence of an SML and the high potential for styrene to migrate into food from FCM, the European Commission proposed a draft measure setting an SML for styrene of 40 ppb, based on the tolerable daily intake (TDI) suggested by the World Health Organization (WHO) for styrene in drinking water.
The European Commission subsequently requested EFSA to review the potential genotoxicity of styrene following oral exposure and its safety for use in plastic FCM with an SML of 40 ppb.
As the WHO TDI predates the new scientific information emerging from the 2019 IARC classification and EFSA opinion in 2020, EFSA conducted a new assessment to determine whether the 40 ppb limit for styrene in food was adequate to ensure safety, evaluating, among others, the studies reported in the 2019 IARC monograph.

EFSA concluded that the reviewed studies did not show evidence of genotoxic effects of styrene following physiological exposures, including oral exposure.
For substances for which no genotoxic effects have been found, EFSA’s Note for Guidance for FCM states that an SML of up to 50 µg/kg food would not pose a health risk. Therefore, the use of styrene in the production of FCM with a migration limit set at 40 µg/kg food does not pose a health risk to consumers.

EFSA invited interested parties to submit comments on the draft opinion by 28 January 2025.

Materials intended to come into contact with drinking water

For materials intended to come into contact with drinking water, the main obligations set out in Directive (EU) 2020/2184 and related Regulations cover several key aspects. The Directive requires that such materials are safe, comply with strict hygiene standards and subject to constant monitoring and control.

In particular, Member States should ensure that materials used for the extraction, treatment, storage or distribution of drinking water:

1. Do not compromise human health:
   The materials should not release substances that may alter the quality of the water in such a way as to damage human health, respecting the safety limits defined by the directive.
2. Do not negatively affect the colour, smell and taste of the water:
   The materials should not perceptibly alter the water from an aesthetic or sensorial point of view (colour, smell and taste), ensuring that the water remains pleasant to consume.
3. Do not promote microbial growth:
   Materials should not promote the growth of pathogenic microorganisms or other microorganisms that could compromise the healthiness of the water.
4. Do not release contaminants at levels higher than necessary:
   Materials should avoid the release of contaminants (such as heavy metals, hazardous chemicals, etc.) in quantities that may exceed the limits established by regulation, while ensuring the correct functioning of the material for its intended purpose.

These requirements are essential to ensure that drinking water remains safe and of good quality for consumers, protecting public health and ensuring the reliability of the distribution network.

New European drinking water system

The new European system introduced by Directive (EU) 2020/2184 establishes precise rules for the choice of materials and objects that are used in plants for the treatment, storage, supply and distribution of water intended for human consumption. The aim is to establish, through implementing acts, a first positive European list of starting substances, procedures and methods for testing and accepting materials and products.

Timing and transition process

The new regulation, regarding materials intended for contact with drinking water, applies from 2026 for new objects placed on the market, while objects already compliant and installed before that date will have a transition phase until 2032.

In conclusion, the choice of materials for contact with drinking water is essential to guarantee the quality and safety of water and the protection of public health, as well as compliance with current legislation.

SVHC and packaging

With regard to the use of SVHC substances in packaging materials and products, packaging producers and importers must comply with some requirements set out in the REACH regulation: they must ensure that all chemical substances present in the packaging are registered, evaluated and, if necessary, authorised; if a package contains an SVHC substance in a concentration higher than 0.1% by weight, the producer or importer must inform the users of the packaging and provide information on the substance, including its identification and any risks to health and the environment.
Companies should try to reduce the use of SVHC substances in packaging, adopting safer alternatives or optimising production processes. This is to reduce the risk of damage to human health and the environment and ensure compliance with European regulations.

SVHC and food packaging

The obligations for SVHC substances must also be respected for food packaging.
Food packaging may contain SVHC substances (such as plasticizers, colorants, stabilizers or additives) which, if released into the food, could pose a risk to human health. If a SVHC substance is present in concentrations above 0.1% by weight in the packaging material and can migrate into the food product, there may be a risk to the consumer.
The risk assessment of SVHC (Substances of Very High Concern), as well as all other substances considered potentially dangerous, in food packaging is a fundamental part of safety management and compliance with European regulations, in particular food safety legislation, such as Regulation (EC) 1935/2004.

Detection and identification of SVHC substances

The first step in the risk assessment is to identify whether there are any hazardous substances in the food packaging. If there are any SVHCs among them, this involves:

• Materials Analysis:
  Examine the materials used to produce packaging, such as plastic, paper, metal, varnishes and adhesives.
• Consultation of the candidate list:
  Check whether some of the substances used in the materials are included in the candidate list, which is constantly updated by the European Chemicals Agency (ECHA).
• Migration risk assessment:
  One of the crucial steps in the risk assessment is to determine whether the SVHC substance migrates from the packaging material to the food in quantities that may be dangerous to human health. Migration is influenced by various factors, including the type of packaging, conditions of use, chemical properties of the substances.

Conclusions

Risk assessment of hazardous substances, including SVHCs, in food packaging is a complex process that requires a combination of chemical analysis, migration testing and compliance with food safety regulations. Companies must ensure that packaging does not release hazardous substances in quantities that could compromise consumer health and food, managing risks through preventive measures, such as the use of appropriate materials and continuous verification of compliance with current legislation.