What is CLP?
Chemical Hazard communication in the EU 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. CLP is based on the United Nations’ Globally Harmonised System (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.
Revision of CLP is no trivial matter
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 sectors relying on chemicals. This is what we call a “ripple effect” of chemicals legislation on value chains relying on chemicals.
What causes this effect? 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 won’t want to have a product labelled as hazardous in their portfolios– the so-called “blacklisting” effect.
Chemical industry position on the upcoming revision: 8-point Action Plan for “surgical” revision
Cefic supports the goals of the Chemicals Strategy for Sustainability. We are committed to working with the European institutions and EU Member States to ensure the reforms of CLP and REACH, the cornerstones of the EU chemicals law, are done in a targeted “surgical” way so that they effectively tackle the areas where improvement is needed without a complete overhaul of the well-functioning legislation.
Impact on value chains should be accounted for
Since the changes to the CLP will have impacts all across value chains, we believe it is essential for the European Commission to perform a careful analysis to identify whether and how strategic and essential value chains may be negatively impacted by the CLP reform, and how to protect or support these value chains if/when needed. In fact, an economic analysis of the impacts of the Chemicals Strategy for Sustainability done by Ricardo Energy & Environment has found that as many as 12,000 substances out of 24,000 registered could be affected by proposed changes to CLP and subsequent bans and restrictions under GRA (generic approach to risk management). The value chain impact therefore warrants a more detailed examination before any policy changes are introduced as this may negatively affect the EU’s efforts to (re)-establish certain value chains in the EU.
EU CLP should be aligned with the UN process
EU’s CLP is based on the United Nation Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS), which is a well-established mechanism agreed in 1992 [LS1] for ensuring consistent communication of safety of chemicals all over the world. Understanding the need for action, we believe that the EU needs to do much more to secure addition of new hazard classes at the UN level (UN GHS) first before doing this unilaterally at the EU level. Doing it the other way around undermines trust in the well-functioning global system and contradicts Strategic Approach to International Chemicals Management (SAICM) negotiations which calls for all countries to implement the global UN GHS classification.
While it is possible for the EU to propose an update to UN GHS in line with the updated CLP, there is so far no guarantee that the EU proposal will be accepted by all parties. A temporary divergence could then become a long-term deviation.
Adding new hazard classes to CLP now before the UN GHS process does not add any value from the public health and environment perspective either: EU REACH already regulates all substances that would be covered by adding new hazard classes under CLP.
Evidence-based approach for assessment criteria for new hazard classes
For substances with Endocrine Disrupting properties, we call for criteria that fully reflect the WHO (UN World Health Organisation) definition, both for category 1 and for category 2 sub-divisions, taking into consideration the fact that the adverse effect should be a consequence of an endocrine mode of action, with corresponding evidence available.
As to the classification of mixtures, we ask for pragmatic concentration limits to be introduced, consistent with the classification of adverse effects (0.1% or higher, depending on the adverse effect which, in principle, should already be classified under CLP).
We support the PBT/vPvB criteria consistent with existing REACH requirements. One of the potential changes to CLP is to also identify and label substances with Mobile (M) or Very Mobile (vM) properties. However, the technical and policy discussions over the past years have confirmed the absence of a reliable and robust methodology that would make it possible to decide whether a substance can qualify as Mobile or Very Mobile. For this reason, we need to use additional data and “weight of evidence” approach.
Sufficient transition period to implement changes will be needed
The introduction of new hazard classes will require reclassification and new labelling of all substances. Once substances are reclassified and relabelled, mixtures of substances will have to be reclassified and relabelled in turn.
Formulators of mixtures first need all new classification information on substances before they can update safety information for mixtures. Therefore, two distinct and successive transitional periods for substances and mixtures are needed: at least two years for substances and three years for mixtures..
Our position on other elements of the CLP reform is outlined in this 8-point Action Plan for an effective revision of the EU CLP.