EU New Substance Application for Food Contact Materials

The safety of Food Contact Materials (FCMs) in the European Union is governed by a comprehensive regulatory framework designed to protect public health and ensure the high quality of food. For businesses looking to introduce new materials or substances into the EU market—particularly for plastic FCMs—obtaining approval through the European Food Safety Authority (EFSA) is a critical compliance step.

EU Regulatory Framework for Food Contact Materials

At the core of EU FCM regulation is Regulation (EC) No 1935/2004, which mandates that materials in contact with food must not:

• Endanger human health.
• Bring about an unacceptable change in the composition of the food.
• Bring about a deterioration in the organoleptic characteristics thereof.

For plastic materials specifically, Regulation (EU) No 10/2011 establishes a Union List of authorized substances, migration limits, and test conditions. Any substance not listed must undergo a thorough safety evaluation by EFSA and receive formal authorization before being used in food contact applications.

When Is a New Substance Application Required?

An EFSA application for a new substance in food contact plastic materials and articles is necessary in the following scenarios:

• New Substances or Materials: The substance is not included in the Union List of Regulation (EU) No 10/2011.
• New Uses: The intended application deviates from previously authorized conditions, requiring reassessment.

EFSA Dossier Requirements for New Substances

According to EFSA's technical guidelines, a complete application dossier should include the following:

• Substance Identity and Manufacturing Information

Including chemical name, manufacturing process, purity levels, and impurities.

• Physicochemical Properties

Such as melting/boiling point, decomposition temperature, solubility, and stability.

• Intended Use

Including food types to be in contact with, contact conditions, and substance use levels.

• Migration Testing Data

Provide migration data for the safety assessment.

• Residual Content in the Final Material

Provide residual content for the safety assessment.

• Toxicological Data

As required by EFSA based on exposure levels.

Application Process and Timeline

Once EFSA has completed its scientific risk assessment, the draft opinion is reviewed by the EFSA CEP (Panel on Food Contact Materials, Enzymes and Processing Aids). The final opinion will be published in the EFSA Journal and submitted to the European Commission, which decides on market authorization. If approved, the substance will be added to the Union List in Regulation (EU) No 10/2011.

The EFSA application process typically takes 10–15 months. This includes:

1. A completeness check (~30 working days).
2. Scientific risk assessment (~6 months, extendable by an additional 6 months if supplementary information is required).

Proregulations' EFSA New Substance Services

• PCM Compliance Assessment and Strategy
  We evaluate your substance against existing Union Lists and develop a tailored regulatory strategy for market entry.
• EFSA Scientific Opinion Application
  Our team handles the entire dossier preparation and submission process through the ESFC e-submission system, managing all technical queries from EFSA.
• Migration and Toxicological Testing Oversight
  We coordinate with accredited laboratory partners to ensure all required testing—including migration data and toxicological profiles—meets EFSA's rigorous standards.
• Declaration of Compliance (DoC) Preparation
  Assisting businesses in drafting mandatory DoC documents to verify compliance throughout the supply chain.
• Official Communication and Liaison
  We act as your technical representative in communications with EFSA and the European Commission to ensure a smooth approval process.

If you need to ensure your new food contact substances meet EFSA standards or require assistance with the application process, please contact us.