The European Parliament adopted by 533 votes to 11, with 65 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.

The European Parliament’s position adopted at first reading under the ordinary legislative procedure amends the proposal as follows:

Substances containing more than one constituent extracted from plants

Scientific data on certain substances containing more than one constituent extracted from plants have indicated that specific constituents considered in an isolated way can have hazard properties that might not be expressed in the substance as a whole. Therefore, in order to allow time for a scientific evaluation of the suitability for substances containing more than one constituent extracted from plants to follow the rules on classification of substances containing more than one constituent, a derogation from certain rules should be introduced for those substances.

However, when no relevant information is available on the substance itself, manufacturers, importers or downstream users might apply these classification rules to their substances extracted from plants, in order to maintain the current level of protection and the existing good practice. The Commission should review the rules applicable to the identification and examination of the information on substances containing more than one constituent extracted from plants, within five years of the entry into force of this Regulation and submit, if appropriate, a legislative proposal.

Harmonised classification and labelling proposals

Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity based on scientific justification, allows for similar classification of all substances in the group. The grouping process should be scientifically robust, coherent and transparent for all stakeholders.

Where it is scientifically justified and possible, proposals for classification should prioritise groups of substances rather than individual substances. In the case of a proposal for harmonised classification and labelling of a group of substances, those substances should be grouped together on the basis of clear scientific reasoning taking into account how the available information supports the grouping of substances and allows the properties of the substances to be reliably predicted from other substances in the group.

Product identifiers

The product identifier of a mixture should include the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity, aspiration hazard, persistent, bioaccumulative and toxic, very persistent, very bioaccumulative, persistent, mobile and toxic, very persistent, very mobile properties, or endocrine disruption for human health or the environment.

Labelling

Labels should be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture and should be readable horizontally when the package is set down normally. The label may be presented in the form of a fold-out label .

Where a digital label is used, a data carrier linking to that digital label should be firmly affixed or printed on the physical label or on the packaging next to the label in such a way that it can be processed automatically by digital devices that are widely used.

Where label elements are provided on a digital label only, the data carrier should be accompanied by the statement “More hazard information available online” or by a similar indication.

Where those label elements are provided on a digital label only, suppliers should, upon oral or written request or when the digital label is temporarily unavailable at the time of purchase of the substance or mixture, provide those label elements by alternative means. Suppliers should provide those elements independently of a purchase and free of charge.

Where a supplier affixes or prints a data carrier linking to a digital label, it should ensure that the information on the digital label should be accessible to all users in the Union and should remain accessible for a period of at least 10 years or for a longer period where required by other Union legislation.

Advertisement

Any advertisement for a substance classified as hazardous should indicate, as applicable, the hazard pictograms, signal word, hazard statements. Any advertisement for a substance for sale to the general public should in addition state: “ Always read and follow the information on the product label. ”.

Any advertisement for a substance or a mixture classified as hazardous should not contain statements that are not to appear on the label or packaging of that substance or mixture. When substances or mixtures are placed on the market through distance sales, the offer should clearly and visibly indicate the label elements.

Adaptation to technical progress

The Commission may adopt delegated acts to amend Annex I in order to include labelling elements that may only appear on a digital label. It will regularly evaluate the development of alternative approaches for the classification of substances and mixtures, in particular methods not involving animal testing, and adopt delegated acts to update Annex I of the Regulation to reflect this technical progress, if necessary.

The Commission, acting on behalf of the Union and the Member States, should, in the manner appropriate to their role in the relevant UN fora, cooperate with a view to promoting the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic (PBTs), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT) and very persistent and very mobile substances as well as the adaptation of criteria for alternative approaches, in particular non-animal test methods, and the assessment of the need for new criteria for immunotoxic and neurotoxic substances.’

The European Parliament adopted by 519 votes to 99, with 8 abstentions, amendments to the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures.

The matter was referred back to the committee responsible for interinstitutional negotiations.

Subject

The purpose of the regulation is to ensure a high level of protection for human health and the environment, including the promotion of alternative methods for assessing the hazards of substances and mixtures.

Hazardous substances and mixtures and specification of hazard classes

Members specified that gender differences with regard to the susceptibility to chemicals will be taken into consideration, where relevant.

For the evaluation of substances containing more than one constituent in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘ endocrine disruption for human health’ and ‘endocrine disruption for the environment’ hazard classes, the manufacturer, importer or downstream user should use the relevant available information for each of the known individual constituents, impurities and additives in the substance.

Identification and examination of available information on mixtures

An amendment specifies that where the available test data on the mixture itself demonstrate a lack of biodegradation, persistency, mobility and bioaccumulation properties that have not been identified from the relevant available information on the individual substance, such data should also be taken into account for the purpose of evaluating the mixture.

Product identifiers

The product identifier of a mixture should include the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, endocrine disruption for human health, endocrine disruption for the environment, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard, persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM) properties.

General rules for the application of labels

Labels should be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture and will be readable horizontally when the package is set down normally the label may also be presented in a form of a fold out label . Where the label elements are provided by means of a fold-out label, the front page should contain at least certain information provided in all official languages of the Member State where the product is put on the market along with a reference to the additional information provided on the inside page or pages.

Procedure for harmonising the classification and labelling of substances

The Commission may ask the Agency or the European Food Safety Authority to prepare a proposal for harmonised classification and labelling of a substance or a group of substances . The Agency and the Authority may, on their own initiative, provide scientific advice to the Commission and Member States on substances or a group of substances where a harmonised classification could be necessary to protect human and animal health and the environment.

Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling should prioritise groups of substances rather than individual substances . In the event of a proposal for harmonised classification and labelling of a group of substances, those substances should be grouped together based on clear scientific criteria, including structural similarity and similar evidence-based hazard profiles.

Right to request action by the competent authorities and the Commission

Any natural or legal person, individually or in association, would be entitled to present substantiated evidence to the competent authorities or the Commission on the hazardous properties of a substance or mixture, or of several substances in several mixtures, indicating that these properties may not have been sufficiently taken into account in the classification or labelling process. Where the evaluation indicates that the substance does not meet the criteria for classification in any of the hazard classes referred to in the Regulation, the competent authority or the Commission will initiate a harmonised classification and labelling process.

Access to justic e

Natural or legal persons who have submitted a substantiated report of concern should have access to an administrative or judicial procedure to review the procedural and substantive legality of decisions, acts or omissions of the relevant competent authority under the Regulation.

Advertising

Any advertisement for a mixture classified as hazardous should indicate the hazard pictogram, the signal word, the hazard class and the hazard statements. Any advertisement for sale of mixtures to the general public should, in addition, indicate “ always read and follow the information on the product label ”.

The use of environmental claims should be prohibited for substances and mixtures which are classified as hazardous due to their germ cell mutagenic, carcinogenic, toxic to reproduction, endocrine disruption for human health or the environment, persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), or very persistent, very mobile (vPvM) properties.

Adaptation to technical progress

The Commission should promote and evaluate the development of alternative test methods for classification of substances and mixtures, including new approach methods and in particular non-animal test methods , at least every three years, and adopt delegated acts to update Annex I to this Regulation.

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.