PURPOSE: to amend Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures to improve the single market for chemicals.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: the EU has overall been successful in creating an efficient single market for chemicals. However, some weaknesses or gaps in Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (‘CLP Regulation’) prevent consumers, companies, and authorities from fully benefiting from protection against the dangers posed by hazardous chemicals.
In order to keep pace with globalisation, technological development and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council.
As part of the CLP Regulation revision package, a delegated act will add definitions and scientific and technical criteria to enable substances and mixtures that have endocrine disrupting (‘ED’), persistent, bioaccumulative and toxic (‘PBT’), very persistent and very bioaccumulative (‘vPvB’), persistent, mobile and toxic (‘PMT’), or very persistent and very mobile (‘vPvM’) properties to be classified into established hazard classes.
CONTENT: the Commission proposes to adapt Regulation (EC) No 1272/2008 on the classification, labelling and packaging (CLP) of substances and mixtures as follows:
Comprehensive identification and classification of chemical hazards
The first set of amendments aim at ensuring the comprehensive identification and classification of chemical hazards. They aim to:
- boost the efficiency and effectiveness of the harmonised classification process. The proposal states that harmonised classification for the new hazard classes to be introduced by delegated act will be prioritised. This includes the development of prioritisation criteria to guide the submission of harmonised classification and labelling proposals;
- boost the development of harmonised classifications which enables the Commission to initiate and fund more harmonised classification and labelling dossiers, with the possibility to mandate the Agency or the European Food Safety Authority (the Authority) to develop a dossier;
- improve companies’ classification of substances. Notifiers should be required to provide reasons for divergence from the most severe classification. To address divergences between more recent and obsolete classifications, notifiers should be required to update their notifications;
- improve companies’ classification of substances by introducing three measures to strengthen incentives and provisions for companies to appropriately classify substances. One of them involves making available the reasons for diverging notified classifications in the Agency’s inventory, another one in making the names of notifiers public, while the last measure requires updates of notifications of classifications within a certain early stage deadline.
Improving hazard communication
The proposal lays down measures to:
- strengthen minimum requirements for hazard communication by introducing obligatory formatting rules, such as minimum font size and colour, to increase the readability of labels. The broader use of fold-out labels should be allowed;
- establish a specific framework to ensure that the sale of chemicals in refillable containers does not lead to an increased risk. This sales method would be limited to chemicals with less serious hazards;
- allow for the voluntary digital labelling of chemicals. The proposal provides that some information can be provided only on the digital label and no longer needs to be indicated on the on-pack label. As a rule, only information that is not instrumental in the protection of health and the environment should be moved to the digital label without it being on the on-pack label. Simplified labelling rules will also lead to a highly positive cost-benefit ratio for companies.
- introduce additional derogations for chemicals sold to consumers in bulk, such as fuel, and in very small packaging, such as various writing instruments.
Addressing legal gaps and ambiguities of CLP provisions
Measures to address legal gaps and ambiguities include:
- provisions for distance sales, including online sales, and clear responsibilities for all relevant actors. All online sales will require a supplier to ensure that a substance or a mixture placed on the EU market through distance sales meets the requirements of CLP, in particular on classification, labelling and packaging;
- provisions for notifications to poison centres will be clarified. All relevant actors, including distributors placing chemicals on the market across borders or rebranding/relabelling mixtures, will have to make sure that they notify poison centres across the EU about the relevant information, where necessary.
The Commission estimated that the set of measures enhancing the effectiveness of the Regulation enable direct and indirect savings, of EUR 57.5 million per year for the next 10 years. Amongst the quantified savings, the simplification of the labelling rules would generate more than EUR 39.5 million of savings per year for the chemical industry.