Food Additives and REACH: How to Ensure Compliance with European Legislation Without Unnecessary Complications

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Food additives, such as emulsifiers, preservatives, or sweeteners, are subject not only to food legislation but also to the REACH regulation. This means that even food manufacturers must verify whether their suppliers have properly registered the raw materials and whether valid safety data sheets (SDS) are available. Problems arise when an additive is used in quantities below the registration threshold or when the supplier does not provide the necessary documentation. How can one navigate these situations and avoid the risk of non-compliance with regulations? The solution lies in a systematic approach to raw material verification and cooperation with trusted suppliers who guarantee full compliance with REACH and other requirements.

REACH and food additives: Where chemical regulation ends and food safety begins

Food additives such as emulsifiers, preservatives, or sweeteners often fall into a category of substances that must comply with both chemical legislation (REACH) and specific requirements of food regulations. REACH applies to all chemical substances manufactured or imported into the EU in quantities exceeding 1 tonne per year, which includes many additives used in the food industry. The key difference lies in the fact that REACH focuses on the safety of the substance itself, whereas food regulations (e.g., the EU regulation on food additives) address its use in the final product intended for consumption.

For manufacturers and distributors, it is crucial to distinguish whether a substance is subject only to REACH or also to additional regulations. For example, substances used as processing aids (e.g., certain surfactants in food processing) may be exempt from food regulations but must still meet REACH requirements. Conversely, additives that are part of the final product (e.g., colorants, antioxidants) must, in addition to REACH, undergo an approval process according to food standards. In practice, this means that the safety data sheet (SDS) and REACH registration are only the first step—verification of whether the substance meets the criteria for use in food must follow.

When is REACH registration required and how to avoid unnecessary costs

Registration under REACH is mandatory for all substances manufactured or imported in quantities exceeding 1 tonne per year, but there are exemptions that can save time and money. For instance, substances used exclusively as food additives or in food contact materials (FCM) may be partially or fully exempt from registration if they are already covered by other regulations (e.g., the EU regulation on food additives). However, this does not mean that REACH does not apply to them at all—the obligation to comply with classification and labelling under CLP/GHS remains in force.

For companies, it is crucial to analyze their portfolio and determine which substances actually require registration. For example, polymers are generally exempt from registration, but their monomers or additives contained within may require registration. Another cost-saving step is to utilize joint registration through consortia, where testing and documentation costs are shared among multiple participants. In case of doubt, it is advisable to consult with a REACH expert or use tools such as the ECHA database, which provides an overview of already registered substances.

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Safety Data Sheets (SDS) and CLP Labelling: How to Communicate Risks Correctly

The Safety Data Sheet (SDS) is a fundamental document for communicating risks associated with chemical substances, including food additives. It must contain all relevant information about the substance's properties, its hazardous characteristics, safety measures for handling, and first aid. For food additives, it is particularly important that the SDS reflects not only the requirements of REACH and CLP but also the specific conditions of use in the food industry. For example, for substances classified as irritants or sensitizers, it must be clearly stated whether their use in food is safe and under what conditions.

Labelling according to CLP/GHS is another critical point. Even if a substance is intended for food purposes, all relevant hazard symbols, standard hazard statements (H-phrases), and safety handling instructions (P-phrases) must be included on the packaging. Exceptions apply when the substance is supplied in a concentration below the classification thresholds – in such cases, labelling may be simplified. However, it is always necessary to verify whether there are specific requirements for food applications that may affect classification (e.g., limits for residual quantities in the final product).

Practical Tips for Ensuring Compliance: From Risk Analysis to Documentation

The first step to ensuring compliance with legislation is a thorough risk analysis for each substance in the portfolio. This includes determining whether the substance is subject to REACH, CLP, food regulations, or a combination of these. For food additives, it is advisable to create a clear matrix that tracks requirements for registration, safety data sheets, labelling, and any certifications (e.g., for materials coming into contact with food). This helps avoid duplicate work and ensures that no requirement is overlooked.

Documentation should be maintained systematically and updated with every change in legislation or substance properties. In addition to SDS and registration documents, it is important to retain records of testing, risk assessments, and communication with suppliers. For companies that do not have in-house REACH experts, it is advantageous to collaborate with external consultants or use specialized software tools for chemical safety management. Regular training of employees in handling chemical substances and knowledge of current regulations then minimizes the risk of errors and penalties.

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How to Distinguish a Food Additive from an Industrial Chemical: Critical Points for REACH Registration

The boundary between food additives and industrial chemicals is not always entirely clear, which can lead to misunderstandings when assessing obligations under the REACH regulation. The key factor is the primary purpose of the substance: if a substance is manufactured or imported exclusively for use in food, feed, or as a processing aid in food production (e.g., extraction solvents), it falls under food legislation and REACH does not apply. However, this does not mean that manufacturers or importers should overlook safety documentation—it must be prepared in accordance with specific food regulations, such as Regulation (EC) No 1333/2008 on food additives.

The issue arises with substances that have dual uses, such as certain emulsifiers, preservatives, or colorants, which are used in both the food industry and cosmetics or industrial applications. In such cases, it is necessary to assess whether the substance is placed on the market for non-food purposes as well. If so, it must be registered under REACH, even if its food-related use constitutes only a small portion of the total volume. It is recommended to conduct a detailed analysis of the portfolio and consult with experts in chemical legislation to avoid overlooking registration obligations.

Certifications and Voluntary Standards: How to Strengthen the Credibility of Food Additives

While REACH and CLP establish the basic legal framework for the safety of chemical substances, voluntary certifications and standards play a significant role in the food sector. These can serve as proof of compliance with the highest safety and quality requirements and facilitate access to demanding markets. Among the most widespread are certifications according to the FSSC 22000 (Food Safety System Certification) standard, which combines food safety management system requirements with regulations for risk prevention. Another important certification is HACCP (Hazard Analysis and Critical Control Points), focused on identifying and controlling critical points in the production process.

For manufacturers and distributors of food additives, obtaining ISO 22000 certification is also advantageous, as it integrates HACCP principles with management system requirements. These certifications not only enhance credibility with customers but also facilitate communication with regulatory authorities and reduce the risk of non-compliance during inspections. It is also important to monitor the specific requirements of target markets – for example, in the USA, it is necessary to comply with FDA (Food and Drug Administration) regulations, while in Japan, strict standards under the Food Sanitation Act apply.

Managing Documentation and Updating Safety Data Sheets: How to Avoid Penalties and Delays

Safety Data Sheets (SDS) and labelling according to CLP are living documents that must reflect the current state of knowledge about a substance and its classification. In the food industry, where work often involves substances sensitive to legislative changes, regular updating of SDS is crucial. Under the REACH Regulation, the Safety Data Sheet must be updated without undue delay as soon as new information on risks emerges or the classification of the substance changes. This includes, for example, new toxicological or ecotoxicological data, changes in exposure scenarios, or updates to harmonised classification under CLP.

For effective document management, it is recommended to implement a system of regular reviews, ideally every 6 to 12 months, even if no legislative changes have occurred. It is also important to monitor updates from ECHA (European Chemicals Agency) and other relevant sources, such as the EFSA (European Food Safety Authority) database. Automated SDS management tools can significantly streamline this process, especially for companies with an extensive product portfolio. Do not forget to train employees who work with the documentation – insufficient knowledge of current requirements can lead to errors with serious legal and financial consequences.

Are You Unsure About the Compliance of Your Raw Materials?

GCG Group provides complete safety documentation, including SDS and technical data sheets, for every food additive. Our experts will advise you on assessing registration obligations and selecting suitable alternatives to ensure your production meets all legislative requirements. Contact us – or browse our catalog of over 1,300 products right away.