REACH and CLP in Practice: How to Correctly Classify Plastic and Rubber Additives According to New Requirements
New requirements for the classification and labelling of plastic and rubber additives under REACH and CLP are changing the rules of the game. How can you avoid mistakes that could lead to penalties or product withdrawals from the market?
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The REACH legislation and CLP/GHS regulations significantly impact how manufacturers and processors of plastics and rubber handle chemical additives. From updated harmonized classifications to obligations regarding safety data sheets (SDS), any error in classification or labeling can result not only in legal risks but also in a loss of competitiveness. In this article, we will explore the key changes that need to be considered when working with additives such as plasticizers, stabilizers, fillers, or flame retardants, and how to correctly proceed with their integration into the production process.
REACH and CLP: The Fundamental Framework for Additives in Plastics and Rubber
REACH Regulation and the CLP Regulation are key legislative tools for ensuring the safety of chemical substances in the European Union, including additives used in plastics and rubber. REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) requires the registration of all substances manufactured or imported in quantities exceeding 1 tonne per year, with additives being no exception. For manufacturers and distributors, this means an obligation to gather comprehensive data on the properties of substances, their toxicological and ecotoxicological profiles, and potential risks during use. CLP (Classification, Labelling and Packaging) then builds on this data and sets rules for the classification, labelling, and packaging of chemical mixtures and substances according to the GHS (Globally Harmonised System).
In practice, this means that every additive for plastics or rubber must be assessed for potential hazards such as toxicity, flammability, corrosivity, or environmental risks. The results of this assessment are reflected in safety data sheets (SDS) and labels, which must be provided with the product. For manufacturers of plastic and rubber products, it is crucial to keep track of which additives they use and ensure that they comply with all REACH and CLP requirements. This also includes monitoring updates to the regulations, as the list of substances subject to authorisation or restrictions is regularly expanded.
Classification of Additives According to CLP: Step by Step
The classification of additives under the CLP Regulation begins with the identification of all relevant hazardous properties of the substance. For additives in plastics and rubber, the most commonly assessed properties include physico-chemical characteristics (e.g., flammability, oxidative potential), health effects (acute toxicity, irritancy, sensitisation, carcinogenicity), and environmental impacts (toxicity to aquatic organisms, bioaccumulation). Each of these properties is evaluated using standard test methods, the results of which are compared against the criteria set out in the CLP. If a substance meets the criteria for any hazard category, it must be classified and labelled accordingly.
The classification process involves several key steps: gathering available data (e.g., from REACH registration, scientific studies, or supplier safety data sheets), evaluating their relevance and reliability, and subsequently assigning appropriate hazard symbols, signal words ("Danger" or "Warning"), and standardized hazard statements (H-phrases) and safety handling instructions (P-phrases). For mixtures, such as masterbatches or finished plastic or rubber composites, classification is carried out based on calculation methods or testing of the entire mixture. It is important that the classification is regularly updated in line with new scientific findings or changes in legislation.
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Safety Data Sheets (SDS): How to properly prepare documentation for additives
A Safety Data Sheet (SDS) is a fundamental document that provides users of plastics and rubber additives with all the necessary information on the safe handling, storage, and disposal of a substance. Under the REACH regulation, the SDS must contain 16 mandatory sections covering substance identification, composition, hazard information, first aid measures, fire-fighting instructions, measures in case of accidental release, handling and storage instructions, exposure control and protective equipment, physical and chemical properties, stability and reactivity, toxicological and ecological information, disposal instructions, transport information, regulatory information, and other data.
For additives in plastics and rubber, it is crucial that the SDS accurately reflects the current classification under CLP and includes specific recommendations for their use in industrial processes. For example, at processing temperatures above 150 °C, potential risks of volatile substance release or additive decomposition must be stated. Furthermore, it is important to specify compatibility with other mixture components and possible interactions that could lead to undesirable reactions. The SDS must be prepared in the language of the country where the product is placed on the market and must be easily accessible to all users in the supply chain. Regular updates to the SDS are mandatory, particularly in the event of classification changes or new scientific findings.
Practical Challenges and Recommendations for Plastics and Rubber Manufacturers and Processors
Implementing REACH and CLP requirements in practice presents several challenges for plastics and rubber manufacturers and processors. One of these is ensuring transparency in the supply chain, as every participant must have access to up-to-date information on the additives used. This requires close cooperation with raw material suppliers and regular communication regarding changes in classification or safety data sheets. Another challenge is the correct risk assessment during additive processing, particularly at high temperatures or under mechanical stress, which can affect material stability and safety.
To minimize risks and ensure compliance with legislation, it is recommended to implement an internal audit system that will regularly check the up-to-date documentation and correctness of classification. Furthermore, it is advisable to train employees in the safe handling of chemical substances and to regularly update work procedures. In case of uncertainty regarding classification or SDS processing, it is possible to use the services of expert consultants or laboratories that will provide an independent assessment. By following these steps, manufacturers can not only meet legislative requirements but also enhance the safety of their processes and increase customer confidence in their products.
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Impact of new REACH requirements on the registration of additives for plastics and rubber
The REACH regulation amendment introduces several key changes for manufacturers and processors of plastics and rubber additives that must be considered as early as the product development phase. One of the most significant is the extension of obligations for substances present in concentrations above 0.1 % w/w, which must now be registered even if they are part of mixtures or polymers. This particularly affects additives such as plasticizers, stabilizers, flame retardants, or colorants, which were previously often considered part of the polymer and thus exempt from registration requirements. Manufacturers must now conduct a detailed analysis of their product compositions and verify whether individual components meet the conditions for registration under the current ECHA requirements.
Another challenge is the tightening of requirements for information on hazardous properties of substances, especially concerning endocrine disruptors or substances with persistent, bioaccumulative, and toxic (PBT/vPvB) properties. Additive manufacturers must ensure that these properties are properly evaluated using standard testing methods and that the results are included in the registration documentation. In practice, this means that laboratory testing and toxicological studies must be conducted in accordance with the latest scientific knowledge and methodologies, which may extend the time required to bring a product to market.
Classification and Labelling of Additives under CLP: Specifics for Plastics and Rubber
The classification of additives under the CLP Regulation requires careful assessment of their physico-chemical, toxicological, and ecotoxicological properties. For plastics and rubber additives, special attention must be paid to substances that may release volatile organic compounds (VOCs) or degrade into hazardous by-products during polymer processing. For example, some brominated flame retardants may release corrosive or toxic gases at high temperatures, which must be reflected in the classification and subsequent labelling of the product.
For proper classification, it is essential to have up-to-date safety data sheets from raw material suppliers and the results of your own tests available. In the case of additive mixtures, it is necessary to follow the CLP rules for mixture classification, which include calculation methods or experimental testing. Manufacturers should also monitor updates to the harmonised classifications of substances in Annex VI of the CLP Regulation, as changes in the classification of individual components may require a reassessment of the entire product. Labelling on packaging must be clear, legible, and contain all mandatory elements, including pictograms, signal words, and standard hazard statements (H-phrases) and safety instructions (P-phrases).
SDS for Additives: How to Ensure Compliance with REACH and CLP Requirements in Practice
Safety data sheets (SDS) for additives in plastics and rubber must be prepared to provide comprehensive information on hazardous properties, safe handling, and measures in case of an accident. A key requirement is that the SDS contains up-to-date classification data according to CLP, including all relevant H- and P-phrases. For additives that are mixtures, it is necessary to state the classification of each hazardous component with a concentration above the threshold value specified in the CLP. It is also important to include information on physico-chemical properties, such as flash point, viscosity, or solubility, which may affect safety during processing.
In practice, deficiencies are often encountered in Section 11 (toxicological information) and Section 12 (ecological information), where detailed data on health and environmental effects must be provided. Manufacturers should collaborate with toxicologists and ecotoxicologists to ensure that this information is accurate and up to date. SDS must also be updated regularly, particularly if there is a change in the product composition, its classification, or legislative requirements. It is recommended to implement an internal SDS management system to ensure that all documents comply with current regulations and are easily accessible to customers and regulatory authorities.
Unsure about the classification of your raw materials?
GCG Group provides up-to-date Safety Data Sheets (SDS) and technical documentation for every raw material supplied, in compliance with REACH and CLP. Our experts will be happy to advise you on the specific requirements of your production and help ensure full legislative compliance. Contact us – or browse our catalogue of over 1,300 products right away.
