The print Industry will be impacted by changes to the EU CLP regulation, writes Elaine Campling from ESMA HSEP Committee and Chemical Compliance Advisory Services.
The European Commission has published the Delegated Act (Regulation 2023/707) for the addition of new hazard classes to the EU CLP Regulation, (EC) No.1272/2008 on the classification, labelling and packaging of substances and mixtures. New classification criteria and hazard statements will be introduced into the EU CLP Regulation to account for the new hazard classes, which are as follows:
- Endocrine disruptors, one category for human health and one for the environment;
- Persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB);
- Persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM).
A consultation on the proposals took place during the autumn of last year. Industry and trade associations used the public consultation to object to the inclusion of the six new hazard classes into the EU CLP Regulation, outside of the United Nations Globally Harmonised System (UN-GHS). The UN-GHS is the internationally agreed system for the classification and labelling of chemicals from which the CLP Regulation was originally derived.
Despite this, the Delegated Act was forwarded to EU Parliament and Council for agreement in December of last year. Some significant changes to the original proposal had been made, for example to the classification criteria for endocrine disruptors and hazard statements for PBT/vPvB and PMT/vPvM substances.
The addition of the new hazard classes will result in greater differences between the EU CLP Regulation and other countries and jurisdictions that have adopted the UN-GHS. It is perceived as being in opposition to the principle of harmonised regulation at a global level for the classification and labelling of chemicals.
However, according to the Commission, the new hazard classes offer better protection of humans and the environment, in line with the Chemical Strategy for Sustainability. At the December meeting of the UN GHS, the formulation of a new informal working group was agreed to consider the ‘most appropriate way to take forward the EU’s proposed new ‘hazard classes’ (…) It is likely this work will take several years to resolve.’
There is also a proposed revision to other areas of the CLP Regulation i.e. aside from the introduction of the new hazard classes. This includes planned changes to labels, aspects dealing with distances sales, harmonised classification processes, and wider use of fold-out labels. This proposed revision also includes new provisions for digital labelling. It is intended that only label elements that are not ‘instrumental’ in the protection of health and safety and the environment, and not obligatory under GHS may be replaced by a digital label. The digital label must comply with certain criteria e.g. it must be searchable, available in less than two clicks and not track any user data.
The responses submitted to a recent consultation on these changes will now be considered by the EU Commission, following which a legislative proposal will be submitted to the EU Parliament and Council.
The EU CLP regulation remains a necessary focus for attention at the ESMA HSEP Committee meetings. Please join us there for discussions on this and other important topics: www.esma.com/committees/hsep.
