Overview

The safety of food contact materials (FCMs) in the European Union is governed by a comprehensive regulatory framework aimed at protecting public health and ensuring the quality of food. For businesses looking to introduce new materials or substances into the EU market, especially for plastic FCMs, obtaining approval through the European Food Safety Authority (EFSA) is a critical compliance step. This article provides a detailed overview of the regulatory landscape, application process, data requirements, and how specialized consulting services can streamline market access.

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, or

• 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:

1. New Substances or Materials
   The substance is not included in the Union list of Regulation (EU) No 10/2011.

2. New Uses
   The intended application deviates from previously authorized conditions, requiring reassessment.

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.

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 leves.

Frequently Asked Questions (FAQ)

How long does the EFSA application process take?
Typically, 10–15 months. This includes:

• A completeness check (~30 working days),

• Scientific risk assessment (~6 months), and

• European Commission decision.
  More complex cases may take up to 18–24 months.

What are the typical costs involved?
Costs vary depending on the complexity of the substance. A standard application may cost between €70,000–€150,000, covering testing, dossier preparation, and EFSA communication.

What data is required for the application?
Submissions must include:

• Analytical data (e.g., impurities analysis, migration study etc.),

• Physicochemical properties

• Manufacturing details,

• Toxicological studies,

• Safety evaluations.

What if an application is rejected?
Applicants can revise and resubmit after addressing EFSA’s scientific concerns or providing additional data.

Full-Service Solutions for EFSA Applications

REACH24H provides end-to-end support for new substance applications under EFSA regulations. With deep expertise in EU FCM compliance, we help clients accelerate market access and reduce regulatory risk.

Our Services Include:

• Regulatory Feasibility Assessment
  Evaluate whether your substance qualifies as a “new substance” and assess the possibility for EFSA submission.

• Dossier Compilation
  Prepare complete technical dossiers, including:

• Impurity data,

• Dietary exposure modeling,

• Toxicological profiles.

• Application Management
  Support through EFSA’s online submission portal, monitor application status, and coordinate pre-test notifications with labs.

• Response to EFSA Inquiries
  Provide scientific justifications and data clarifications during the risk assessment process.

• Customized Compliance Strategies
  Tailor strategies based on material type (e.g., bio-based polymers like PHA) and help clients meet sustainability goals under the circular economy framework.

Step-by-Step Application Workflow

1. Initial Consultation
   Clarify material type, intended use scenarios, and compliance targets.

2. Pre-Assessment
   Evaluate regulatory compliance pathways and establish submission strategies.

3. Data Generation & Testing
   Supervise related tests (impurity analysis, migration and toxicology studies) in our collaberating labs.

4. Dossier Submission
   Compile and submit the application dossier in line with EFSA’s format and requirements.

5. Scientific Opinion Monitoring
   Track the evaluation process, respond to EFSA requests, and ensure timely progression to final decision.

6. Post-Approval Support
   Assist with ongoing compliance in the EU market and offer training on regulatory updates.

Why Choose Us?

• Proven Track Record
  Extensive experience in securing successful EFSA approvals for new plastic food contact materials.

• Regulatory Intelligence Network
  Close collaboration with EFSA and EU national authorities.

• One-Stop Testing Coordination
  Strong partnerships with accredited labs for impurity analysis, migration, and toxicology studies.