REACH / CLP
EU Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
The Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), which entered into force on 1 June 2007, is by far the most important piece of the EU chemical legislation. It has been created to ensure the safe use of all chemicals in the EU, both manufactured and imported. In many respects, it represents an ambitious, innovative approach to chemicals management.
REACH applies to all uses of all chemical substances throughout their life cycle (from production to disposal). It imposes obligations on all actors in the supply chain to collect or generate data on the substances they use to assess how to manage the risks to human health and the environment during the production and use of these substances.
The key principle of REACH is “no data – no market”, which means that no substance can be manufactured, used or imported in the EU without registration with the European Chemicals Agency (ECHA).
The full implementation of the REACH Regulation is a top priority for the chemical industry.
Cefic (European Chemical Industry Council) and its members fully support REACH and believe this legislation is fit for purpose. More than 20,000 substances have been registered with the European Chemicals Agency (ECHA), with corresponding physico-chemical, toxicological, ecotoxicological and use data, thereby creating the world’s largest and most comprehensive database on substances, their properties and behaviour.
The registration phase is not the last part of REACH. The Regulation stipulates that companies should regularly update their registration dossiers to ensure that the data on safety of chemicals is complete and up-to-date. New chemicals must be fully registered too. Now that the last registration deadline has passed, registrants are starting the process of reviewing their dossiers to identify and tackle any data gaps.
Another important aspect for EU’s chemical industry is the enforcement of REACH on imported products, which is crucial to ensuring the level playing field between EU-based and foreign manufacturers. Therefore, we support all enforcement efforts undertaken by EU member states to check compliance of imported substances, mixtures, and articles.
The REACH revision is an opportunity to continue reducing exposure to the most harmful substances and continue building a predictable regulatory framework that enables industry and authorities to focus resources where increased added value exists, including development of safe and sustainable alternatives, where needed, and simplifying administrative processes.
Today more than ever Europe needs a robust domestic chemical industry to reduce strategic dependency on other regions. The role of REACH is therefore to boost the industry’s capacity for growth and innovation whilst raising the bar on safety.
The chemical industry will go through a double twin transition (climate neutrality, Chemicals Strategy for Sustainability, circularity and digitalisation).
The guiding principles of the revision should be prioritising regulatory actions that bring the most benefits to health and the environment, keeping the regulatory framework as stable as possible and maintaining coherence of REACH with all other pieces of EU legislation. Last but not least, advances in risk assessment methods, human and environmental monitoring, predictive toxicology and alternatives to animal testing need to be reflected in this revision.
Find here a 10-point plan for improving the Regulation put forward by the chemical industry.
In a series of information campaigns, seminars and meetings with competent authorities, HACI has been promoting knowledge of the Regulation among its members and across the entire supply chain.
Regulation on classification, labelling and packaging
CLP – Regulation (EC) No 1272/2008
Chemical hazard communication in the European Union is regulated by the Classification, Labelling and Packaging (CLP) Regulation through harmonised criteria for classification of substances and mixtures and rules on labelling and packaging for hazardous substances and mixtures.
The CLP Regulation is based on the United Nations’ Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS). It requires manufacturers, importers or downstream users of substances or mixtures to classify, label and package their hazardous chemicals appropriately before placing them on the market. The information is provided on the label to allow safe use of products, and the design of packaging depends on the hazards of the product it contains.
The Chemicals strategy for sustainability provides for a significant revision of the CLP Regulation. One of the key changes mulled by the European Commission is to introduce new hazard classes to cover the substances with the following properties: Endocrine Disruptors (ED); Persistent, Bioaccumulative and Toxic (PBT); very Persistent and very Bioaccumulative (vPvB); Persistent, Mobile and Toxic (PMT) and very Persistent and very Mobile (vPvM) substances.
As a result, chemical manufacturers will need to update labels on packaging, Safety Data Sheets and REACH registration dossiers.
However, the main impact lies with second-order effects of CLP Regulation, so its reform will have far-reaching consequences for all other value chains relying on chemicals.
The changes in classification under CLP automatically trigger restrictions and bans of chemicals under the generic approach to risk management (GRA). Being assigned a new hazard class will therefore mean automatic restriction or ban without any substance-specific risk assessment.
While this option already exists today under current REACH legislation, the number of substances subject to these generic bans and restrictions will grow significantly as more hazard classes are to be added to CLP. Manufacturers may also decide to discontinue a certain substance or product as they will not want to have a product labelled as hazardous in their portfolios, that is, placed on a so-called “blacklist”.
The chemical industry’s position on the upcoming revision is summarised in an 8-point plan for an effective and smart revision.