Explanatory Memorandum to COM(2022)748 - Amendment of Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2022)748 - Amendment of Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures. |
|---|---|
| source | COM(2022)748  |
| date | 19-12-2022 |
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
Among its actions, the European Green Deal provides for the strengthening and simplification of the legal framework for chemicals to ensure a toxic-free environment 1 . The revision of Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (‘CLP Regulation’) 2 was announced by the Chemicals Strategy for Sustainability 3 , adopted on 14 October 2020. The targeted revision of the CLP Regulation, as part of the strategy, was welcomed by the Council 4 and the European Parliament 5 .
The Union has overall been successful in creating an efficient single market for chemicals. However, some weaknesses or gaps in the CLP Regulation described below prevent consumers, companies, and authorities from fully benefiting from protection against the dangers posed by hazardous chemicals. As the EU is committed to the 2030 Agenda for Sustainable Development 6 and its Sustainable Development Goals (SDGs) 7 , this proposal contributes to several of the SDGs, including those to ensure good health and well-being, sustainable consumption and production patterns, and clean water and sanitation 8 .
Contents
- Better identifying and classifying hazardous chemicals
- Improving communication on chemical hazards
- Addressing legal gaps and high levels of non-compliance
- Conclusion
- The second set of amendments consists of five complementary measures.
- Quantitative estimates of cost and benefits
- The amendment to Article 30 clarifies the timeframe for the obligation to update the label by setting a fixed deadline and by clearly defining the start of the transition periods.
First, although certain chemicals and articles may pose risks to human health or to the environment, their hazards are not always properly identified and communicated. The main driver behind this issue are inefficiencies in the procedures for assessing and classifying hazards. Shortcomings in hazard communication also impair consumers’ ability to make informed choices.
Second, there is a high number of erroneous or obsolete classifications of substances, as well as diverging classifications for the same substance in the European Chemical Agency’s classification and labelling inventory (‘inventory), with almost 60% of companies having multiple notified classifications for a single substance 9 . The issue of erroneous, obsolete and/or diverging classification leads to information deficiencies for users of chemicals, which may increase their exposure to those chemicals.
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. The impact of adding these new hazard classes has been assessed as part of the overall impact assessment on the revision of the CLP Regulation 10 .
Appropriate hazard classification determines, among others, the appropriate labelling and packaging of the chemicals in the supply chain, in particular to protect workers, consumers and the environment, but also to enable the single market to function properly. An estimated 55% of EU citizens consider themselves not well informed about the potential hazards of chemicals in consumer products 11 . This is also due to a relatively low level of understanding of certain pictograms, labels and warnings, not least due to the limited readability of labels, detailed information, technical language and often too small font size. This proposal aims to make labelling more consumer friendly, less burdensome for suppliers and easier to enforce by clarifying rules and providing clear exemptions. To this end, it will clarify the concept of refill sales and introduce provisions to facilitate the use of fold-out labels as well as provisions for minimum formatting rules to make labels more readable for consumers. In addition, certain labelling exemptions are provided for chemicals supplied without packaging such as fuel at filling stations, chemicals contained in very small packaging such as pens below 10 ml, chemicals with mild hazards supplied in bulk, and ammunition under specific conditions.
The Chemicals Strategy for Sustainability identifies imported chemicals and online sales as a particular challenge and priority area for action. Many chemicals 12 sold online in the EU, and especially those sold by actors established outside the EU and placed on the EU market, do not meet the legal requirements 13 . Incorrectly classified and incorrectly labelled chemicals result in consumers not being properly informed about the hazards, which ultimately leads to incorrect use, storage or disposal. To achieve the objectives of consumer protection and protection of human health and of the environment, and to ensure compliance with the requirements of the CLP Regulation within the EU, the CLP Regulation will introduce a requirement that suppliers have to ensure that substances or mixtures, including those sold online via distance sales, meet the requirements of CLP, in particular on classification, labelling and packaging. In addition, online offers and advertisements often do not display hazard information, therefore, consumers may not be able to make informed choices at the moment of accepting the online offer or when following up on the advertised chemical. Chemicals’ labelling information should be made available before placing on the market, regardless of the means of sale.
Another provision leading to legal ambiguities relates to the notifications that companies must submit to poison centres for emergency health response. It is essential that poison centres, when answering emergency calls, have all the necessary information on the composition of mixtures so they can provide clear advice to consumers or health professionals. While the CLP Regulation provides for the obligation for downstream users and importers to submit relevant information for emergency health response, it does not explicitly do so for distributors either supplying those mixtures across borders or rebranding or relabelling them. An explicit obligation to do so would close the loop of loss of information submitted to poison centres.
The three problems outlined above highlight why the current legislation fails to sufficiently protect humans and the environment from the hazards of chemicals moving freely within the EU single market and why modifications are needed to facilitate enforcement.
The CLP Regulation revision package therefore aims to:
(i)ensure that all hazardous chemicals, including those with ED, PBT, vPvB, PMT and vPvM properties, are classified adequately and uniformly throughout the EU;
(ii)improve the efficiency of hazard communication by making labels more accessible and understandable for users of chemicals, and provide companies with more flexibility, thereby reducing the administrative burden without lowering safety levels;
(iii)make sure that the rules on chemical hazard classification and communication are applied by all relevant actors in the supply chain.
• Consistency with existing policy provisions in the policy area
The delegated act referred to above complements the present proposal by introducing into Annex I to the CLP Regulation new hazard classes and corresponding classification criteria for substances and mixtures with ED properties for human health and for the environment, as well as PBT, vPvB, PMT and vPvM properties. The proposed provision in this proposal to prioritise the above-mentioned hazard classes for harmonised classification will help achieve the European Green Deal’s vision of a toxic-free environment.
The Chemicals Strategy for Sustainability calls for the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (REACH) 14 and the CLP Regulation to be reinforced as the cornerstones for regulating chemicals in the EU. They should also be complemented by coherent approaches to assess and manage chemicals in existing sectoral legislation, especially in relation to consumer products. The CLP Regulation focuses on classifying chemicals that are hazardous, i.e. which have adverse effects on human health or the environment or adverse physical effects, and on communicating them to users of chemicals and decision makers (consumers, industry and authorities).
Under the CLP Regulation, the decision to classify a substance or a mixture for environmental and human health hazards is exclusively based on existing information. The need to generate any additional data requirements is regulated by REACH. As part of ongoing revision of REACH, a possible extension of data requirements for ED identification and for substances placed on the market in lower volumes is being assessed. These data would be made available for classification, thus further improving how these two regulations work together.
An extension of the generic approach to risk management – which relies on harmonised classification as a starting basis – is currently under review under REACH and product legislation (e.g. cosmetics, toys, food contact materials). Legislation based on pre-market authorisations 15 , such as plant protection products 16 and biocides legislation 17 , also relies on harmonised classification. Those revisions will very likely increase the reliance on harmonised classifications, so that appropriate risk management measures can be adopted.
Several other policy initiatives under the European Green Deal will ensure that consumers have access to updated information on the impact of consumer products on human health and/or the environment. The Ecodesign for Sustainable Products Regulation proposal 18 introduces provisions to regulate consumer products on several sustainability aspects. However, chemical safety is excluded from its scope. This revision proposal therefore complements the Ecodesign for Sustainable Products Regulation proposal in terms of consumer access to information on the dangers of chemicals present in products. The proposal also improves the provision of product information via digital tools, in particular a digital product passport that will gather data on a product and its value chain. This passport is particularly relevant for the introduction of digital labelling because it provides for the mandatory adoption of digital ways for communicating product information. However, the overarching principle that guides what information could be moved to an online label will be to ensure that any information directly linked to user safety and environment protection – and not somehow overlapping, redundant or of little added value – is kept on the physical label that is accessible under all circumstances.
• Consistency with other Union policies
The CLP Regulation plays a central role in hazard classification and communication. 19 Revising it also contributes to the realisation of the EU’s zero pollution vision for 2050 by better managing chemicals’ risks in products (including imports) and combination effects of different chemicals.
Furthermore, this proposal is fully aligned with the EU’s climate objective to avoid and reduce greenhouse gas emissions. While relabelling (recalling chemicals in the supply chain to label and ship them again – cost that is tempered by the transitional provisions allowing substances and mixtures already placed on the market at the date of application not to be re-labelled) and the voluntary substitution of chemicals may generate some greenhouse gas emissions, the overall benefit of contributing to an environment more resilient to climate changes by identifying and reducing hazardous substances has a balancing effect 20 .
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
This proposal has as its legal basis Article 114 of the Treaty on the Functioning of the European Union.
• Subsidiarity (for non-exclusive competence)
In the same way as when the CLP Regulation was adopted, the objectives of this proposed Regulation cannot be sufficiently achieved at Member State level. Given the scale or effects of the proposed action, they can be better achieved at EU level. To solve the same problems, one action at EU level will be less costly and more efficient than 27 different actions.
Action at EU level is crucial to preserve the free movement of chemicals in the single market. Individual actions at national level would impose significant administrative burdens on companies seeking access to the market of more than one EU Member State. Furthermore, chemical pollution and its negative impacts are transboundary by nature. Citizens in one Member State would therefore be affected by the potential inaction in another Member State.
• Proportionality
The initiative does not go beyond what is necessary to achieve the objectives sought.
The supporting impact assessment 21 assesses the impacts of the proposed revision of the CLP Regulation. Both qualitative and quantitative assessment have been undertaken that show that the proposal is proportionate, i.e. that is that environmental and societal benefits are significantly higher than the costs incurred.
• Choice of the instrument
This proposal for revision is a legislative proposal. The CLP Regulation has been adopted by co-decision and therefore its revision needs to be adopted by ordinary legislative procedure. It maintains the choice of instrument as a directly applicable and binding EU Regulation. While the Annexes to the CLP Regulation have been amended several times before, this proposal is a targeted revision of the enacting terms and, where relevant, the related Annexes. Although the CLP Regulation has empowered the Commission to amend certain Articles of the CLP Regulation and the Annexes to adapt them to technical and scientific progress, a number of amendments to these Articles and Annexes are included in this legislative proposal to ease the adoption process as they are linked to the amended provisions which refer to them.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
The CLP Regulation, together with other pieces of EU legislation, was evaluated in 2019 22 . The fitness check’s overall conclusion was that EU chemicals legislation, including the CLP Regulation, meets the objectives. The added value of policy action at the EU level is high and remains relevant. Significant benefits in terms of avoided health and environmental impacts (healthcare costs, productivity losses, suffering and premature deaths, remediation costs, and degradation of environmental/eco-system services) were registered. At the same time, the fitness check identified some significant issues and weaknesses that hold the CLP Regulation back from delivering its full potential. The evaluation pinpointed potential areas of intervention:
·providing harmonised reference values in addition to harmonised classification;
·improving harmonised classification;
·improving and streamlining industry’s classification;
·clarifying rules on hazard labelling;
·reviewing the exemption of certain chemical products from the CLP Regulation;
·addressing the low compliance rate with labelling requirements for the online selling of chemicals;
·closing notification gaps for poison centres;
·improving data quality in the European Chemicals Agency’s (‘the Agency’) inventory.
• Stakeholder consultations
Initial feedback was provided on the inception impact assessment published on the Commission’s ‘Have Your Say’ website 23 . The feedback period ran from 4 May 2021 to 1 June 2021, with 182 comments.
As part of the impact assessment, an open public consultation on the revision of the CLP Regulation ran for 14 weeks from 9 August 2021 to 15 November 2021 24 . The questionnaire was split into two sections, one containing 11 questions for the general public, and one containing 37 questions for experts. Both sections allowed respondents to provide position papers.
The consultation was followed by a targeted stakeholder survey. The survey was open for 6 weeks (from 10 November to 22 December 2021). A stakeholder mapping exercise identified 548 stakeholders, to whom the survey was sent.
Furthermore, extensive discussions on specific issues of the revision of the CLP Regulation were held in three ad hoc meetings of the CARACAL expert group (Competent Authorities for REACH and CLP), with broad Member State and stakeholder participation:
·CARACAL meeting on poison centres and online sales (27 October 2021);
·CARACAL meeting on harmonised classification and labelling prioritisation, predicted no-effect concentration, derived no-effect level, derived minimal effect level and labelling (6 December 2021);
·CARACAL meeting on new hazard classes, more than one constituent substance and self-classification (14 December 2021).
Relevant discussions on specific topics covered by this proposal were also held in other CARACAL meetings.
In addition, 22 interviews were conducted between December 2021 and February 2022 with public authorities, EU agencies, companies and business associations, non-governmental organisations and other organisations. The aim was to complement the findings of the open public consultation, the targeted stakeholder consultation and the views provided by CARACAL members and observers.
Another open public consultation on simplification and digitalisation of labels on chemicals was open for 12 weeks, from 24 November 2021 to 17 February 2022 25 . The launch of that consultation was complemented by a stakeholder workshop on simplification and digitalisation of labelling requirements for chemicals, held on 26 November 2021. Two online surveys, on policy options for digitalisation and for information from professionals and industry users, were also conducted.
Main input on the problems identified:
Harmonised classification and labelling: Most stakeholders welcomed the measures proposed to improve the number of harmonised classification and labelling dossiers, including prioritisation for developing harmonised classifications of substances raising a high level of concern. However, all stakeholders pointed out that those measures should not restrict the Member States’ right of initiative.
Opinions about providing the Commission with the right to initiate harmonisation processes varied, with more respondents strongly agreeing than disagreeing. Civil society, public authorities and citizens were more likely to strongly agree with this than companies and business associations.
Classification: Consultees believe that the Agency should be able to remove incomplete, incorrect or obsolete notifications from the inventory after having informed the notifier. It is also important to improve the Agency’s digital tools for classification and labelling notification. 72% of respondents to the open public consultation believe that the obligation to agree on an inventory entry should be strengthened.
Labelling of chemical products provided in small packages: companies and business associations strongly supported derogations (exemptions) from labelling requirements for these products. They felt that labelling such products is beneficial only when the presence of a hazardous substance has a realistic chance of causing harm to users.
Interviewees consider it beneficial that the selling of refill chemicals is addressed specifically in the CLP Regulation, as this sales method is being used more and more. In the targeted stakeholder survey, companies expressed different opinions on the labelling of chemicals sold in bulk to consumers. Some stressed that hazards of chemicals sold in bulk to consumers (fuels in particular) are not communicated; others emphasised that fuels are sold to trained users who buy them repeatedly and they supported derogations from labelling requirements for substances and mixtures supplied in bulk to consumers. 38% of respondents – digitally connected to reply to the open public consultation that was conducted online – chose digital labels as the best option for receiving information on hazards and safety instructions when buying refill detergents.
Company representatives supported the broader use of fold-out labels as they allow the industry to take advantage of economies of scale, in particular when distributing a chemical in Member States with a low population. National authorities explained that featuring multiple languages makes labels hard to read at the expense of communicating important safety and hazard information. Consumer associations had similar views on this. They proposed adding languages only if there is enough space left on the label after essential safety and hazard information has been included in a readable manner.
Digital Labelling: concerns were expressed about not all product users having access to digital information. However, it was generally accepted that a limited set of information could be provided by digital means only, for example as a complementary hazard communication measure. Public authorities were the most likely to suggest that obligatory provision of information via digital labelling instead of the traditional label could have significant negative health, safety and environmental impacts. Representatives from all stakeholder groups considered that information that is instrumental for the protection of health and the environment must remain on the on-pack label. They especially indicated that the Unique Formula Identifier, the hazard statement, the signal word, and the hazard pictogram should remain on the on-pack label.
Strengthening the rules for online sales received strong and unanimous support from all categories of stakeholders. The overwhelming majority of respondents agree that the online selling of chemicals poses challenges and problems, in particular sales by non-EU traders directly to consumers in the EU. They believe that there is a great need to apply the same obligations under the CLP Regulation (for example labelling, classification and notifications to poison centres) to chemical products sold online, and that the CLP Regulation is not sufficiently adapted to technological progress and societal developments when it comes to online sales, advertising, offerings and distant contracting.
Poison centres: Stakeholders welcomed the clarification of obligations in Article 45 and recognised the problem of ambiguous obligations. Some stakeholders believed that the problem lies with the diverging interpretation of Article 45 by the Member States, leading to specific national requirements. Stakeholders also generally welcomed the clarification of the rules for the obligation to notify poison centres of chemicals for some types of companies. On adding notifications of substances, most respondents think that it is not useful to submit poison centres notifications on substances as this information is already available to poison centres by other means.
• Collection and use of expertise
In analysing the results of the consultation activities in preparation of this proposal, including the open public consultation, targeted stakeholder consultation, interviews and workshops, the Commission has used the services of an external contractor. When assessing the range of issues with enforcement of the CLP Regulation’s labelling provisions, the Commission also took reports by the Agency into account 26 .
• Impact assessment
An impact assessment was carried out, which resulted in a positive opinion with reservations from the Regulatory Scrutiny Board 27 . The Board concluded that the report still contains shortcomings, in particular on the costs and benefits, the methodology used to derive them and the justification of the proportionality of the preferred option. The impact assessment has been revised to fully address the comments received.
Based on the evaluations of existing legislation and stakeholder input, a comprehensive list of potential measures has been drawn up. Following an initial screening, 22 measures have been retained for in-depth assessment. In the end, 17 retained measures have been bundled into three independent policy options, corresponding to each of the three identified problem areas that the revision of the CLP Regulation intends to address.
Regarding the first problem on the classification of chemicals hazards, 4 options were assessed regarding:
1.1.Inclusion of new hazard classes;
1.2.Consistent classification and improving transparency;
1.3.More and prioritised harmonised classification;
1.4.Complementing hazard identification with hazard quantification.
Three options were analysed with regards to the second problem on the communication of chemicals hazards:
1.5.New or revised guidance;
1.6.Improving labelling and packaging and making labelling more flexible;
1.7.Digital labelling.
Finally, three options were developed in response to the third problem on addressing main legal gaps and ambiguities:
1.8.Awareness campaigns;
1.9.Provisions and clear responsibilities for online sales and imports;
1.10.Clarifying provisions for notifications to poison centres.
The preferred policy option (combining options 1.1, 1.2, 1.3, 2.2, 2.3, 3.2 and 3.3) was chosen as it will generate significant and positive health and environmental impacts and incur limited negative economic impacts (considering all retained policy options).
Given the very cross-cutting nature of chemicals, which constitute the basic elements of virtually every material and product that we produce and use, the objectives of this initiative are closely linked to the other goals of the European Green Deal and the Chemicals Strategy for Sustainability, in particular climate neutrality, circularity, biodiversity protection and the green and digital transition of the EU industry. Those objectives also contribute to the achievement of the United Nations Sustainable Development Goals (SDGs), of which 4 are directly relevant for chemicals:
–SDG #3 Good health and well-being: Reduction of exposure of humans and the environment to hazardous substances as meeting one of the existing hazard classes (improvement of self and harmonised classifications) or new ones for EDs and PMT, vPvM, PBT and vPvB substances.
–SDG #6 Clean water and sanitation: Identification of PMT and vPvM substances, which are difficult to remove from waste waters will help to reducing the pollution of water bodies.
–SDG #9 Industry, innovation and infrastructure: Setting criteria to identify hazardous substances and improving both the self and harmonised classification processes will allow the European chemical industry to transition to more sustainable and future-proofed chemicals. Voluntary substitutions of substances classified as hazardous as such or in mixtures will also foster innovation in the chemical industry.
–SDG #12 Ensure sustainable consumption and production patterns: Information on chemical hazards will be improved so consumers and users of chemical can not only protect themselves better but also make informed choices. Self-refill chemicals will be better regulated to allow only refill of mildly hazardous substances. When it comes to online sales of chemicals, customers will have access to more comprehensive information on chemical hazards. Voluntary substitution of hazardous substances in mixtures will also help producing more sustainable chemical products.
• Elements of the legislative proposal
1. Comprehensive identification and classification of chemical hazards
The first set of amendments consists of five measures aimed at ensuring the comprehensive identification and classification of chemical hazards.
First, to boost the efficiency and effectiveness of the harmonised classification process and complementary to the first measure, 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.
A second measure that swiftly boosts the development of harmonised classifications is to allow 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.
Furthermore, companies’ classification of substances will be improved as stronger incentives and provisions for companies to appropriately classify are being introduced through three measures. 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.
The transparency and predictability of the proposals that the Member States, the Commission, manufacturers, importers or downstream users intend to submit to the Agency will be improved through an obligation for them to communicate such intentions to the Agency. The Agency will also be obliged to publish information on such intentions and update information on the submitted proposal at each stage of the procedure for the harmonisation of classification and labelling of substances. For the same reason, a new obligation will be introduced for competent authorities to communicate to the Agency their decision to accept or refuse a proposal for revision of a harmonised classification and labelling submitted to it by a manufacturer, importer or downstream user. In the latter case, the Agency should share the information with other competent authorities.
2. Improving hazard communication
First, minimum requirements for hazard communication will be strengthened by introducing obligatory formatting rules, such as minimum font size and colour, to increase the readability of labels.
Second, selling chemicals in refillable containers has the potential to reduce packaging waste. A framework of specific rules will ensure that this sales method does not lead to an increased risk. For this reason, this method will also be limited to chemicals with less severe hazards.
Third, the proposal introduces a general framework to allow for the voluntary digital labelling of chemicals. Moreover, 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. In addition, information that is obligatory on the on-pack label in accordance with the UN Globally Harmonized System of Classification and Labelling of Chemicals will remain on it.
Fourth, broader use of fold-out labels will be allowed. Advantages in labelling technologies allow us to remove certain limitations, enabling companies to take advantage of economies of scale. This will also further facilitate the free movement of chemicals in the single market.
Additional derogations will also be introduced for chemicals sold to consumers in bulk, such as fuel, and in very small packaging, such as various writing instruments. In these cases, there is a limited risk of exposure, whereas adhering to the standard labelling rules is sometimes disproportionately expensive or even impossible in practice.
3. Addressing legal gaps and ambiguities of CLP provisions
The third set of amendments consists of three complementary measures to address legal gaps and ambiguities in online sales and poison centre notifications.
First, provisions for distance sales, including online sales, and clear responsibilities for all relevant actors will be introduced. To this end, 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. The objective is to ensure a high level of protection of human health and environment, including by facilitating the enforcement of the legislative requirements.
Second, the Digital Services Act 28 ensures that the providers of online marketplaces design and organise their online interfaces in a way that enables suppliers to comply with their obligations regarding product safety information under applicable Union law. This is without prejudice to the Consumer Rights Directive 29 .
Third, the 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.
Health, environmental and economic impacts of the preferred option
The proposed amendments will generate significant and positive health and environmental impacts and will exert limited negative economic impacts. The benefits stem mainly from improvements to the protection of health and the environment, even if the impact assessment could not fully quantify them. The health benefits would result from a reduction in exposure of European citizens to harmful chemicals, as chemical manufacturers would voluntarily substitute some harmful substances. The reduced exposure would save a fraction of the annual costs to public health systems. More benefits will arise from the knock-on effect that the CLP Regulation revision will have on REACH and other downstream chemicals legislation (for example toys, cosmetics, plant protection products or biocides). The measures outlined above will also lead to improvements in the level of safety while reducing administrative burden.
As for human health, a reduced exposure of the environment to hazardous substances will also generate savings, in particular from depollution costs.
Appropriate and uniform hazard classification and communication will allow chemical suppliers and users, as well as public authorities, to take appropriate chemical risk management measures, while preserving integrity on the EU single market and levelling the playing field between companies operating in it.
Improved communication on the hazards of chemicals through better labelling is expected to strengthen consumers’ understanding of the physical, health and environmental hazards of chemicals – and thus, to allow them to make more informed purchasing choices. Simplified labelling rules will also lead to a highly positive cost-benefit ratio for companies.
Prioritisation of the harmonised classification and labelling of substances meeting the criteria for the new hazard classes will allow for increased protection of human health and the environment.
In terms of economic impacts, investment predictability in the single market will be provided on which chemicals will undergo regulatory measures and when. This will offset the costs for industry associated with the addition of new hazard classes and voluntary substitution. The improvement of the classification process, the simplification and clarification of the labelling requirements, as well as stronger convergence of classifications by industry, will harmonise chemical safety assessments throughout the EU. This will lead to efficiency gains. Improving certain legal provisions and closing identified legal gaps will lead to better implementation and compliance, creating a more level playing field for the actors in the single market.
While it has not been possible to quantify and monetise all impacts, it is estimated that the set of measures enhancing the effectiveness of the Regulation enable direct and indirect savings, of €57.5 million per year for the next 10 years. Amongst the quantified savings, the simplification of the labelling rules would generate more than €39,5 millions of savings per year for the chemical industry.
In addition, the impact assessment identified other benefits, of which the magnitude is confounded by a number of problems, including the possibility of estimating the attributable fraction of disease incidence, prevalence and mortality to certain chemical products. However, the human health and environmental benefits of the preferred option stem from a reduced exposure of humans and of the environment to hazardous substances. Savings to public health systems and depollution schemes could amount to a significant fraction of the costs of endocrine related pathologies, estimated to more than €300 million per year.
The initiative will entail significant costs for industry actors placing chemicals on the EU market, both administrative annual costs for compliance with the new rules (€28.47 million for the next 10 years) and adjustment costs for voluntary substitution down the supply chain for substances which would be identified as hazardous according to the new hazard classes (€46.04 million for the next 10 years).
The estimated savings offset the estimated direct and indirect administrative costs, leading to a final estimated surplus of €19.95 million per year for the next ten years. The positive ratio would however turn negative (-26.09 million euro per year for the next ten years) when adjustment costs are factored in. However, the overall cost/benefit ratio will be positive, considering the benefits of an increased protection of human health and of the environment.
• Regulatory fitness and simplification
In line with the Commission’s commitment to better regulation, this proposal has been prepared inclusively, based on full transparency and continuous engagement with stakeholders, listening to external feedback and taking account of external scrutiny to ensure the proposal strikes the right balance.
Consistent classification of substances by companies and improved transparency will help reduce the burden and save costs for industry, as well create a stronger basis for Member States’ enforcement authorities. These measures will contribute to a simplified and searchable inventory (savings estimated at slightly less than €9 million) that would mostly benefit to SMEs. On hazard communication, broader use of fold-out labels (estimated savings of up to around €39.5 million for the detergent industry alone) and introducing exemptions to labelling requirements for some chemicals (savings amounting to more than €10 million) will also add up. The envisaged measures will therefore also contribute positively to the ‘one in, one out’ commitment of the Commission.
The initiative will entail costs for companies that place chemicals on the EU market – both direct costs for compliance with the new rules, and indirect costs for voluntary substitution. Costs for small and medium-sized enterprises (SMEs) will be higher in relative terms as they benefit less from economies of scale and have less capacity to absorb fixed costs. Clarification of the rules on responsibilities for economic actors involved in selling chemicals via distance sales (e.g. via online sales) to EU consumers will, however, improve application of the CLP for all substances and mixtures placed on the market.
The prioritisation of the new hazard classes (to be introduced via separate Delegated act (cf. above) for the harmonised classification and labelling will increase costs for certain companies placing chemicals on the EU market. At the same time, a coherent, EU-wide framework will prevent national initiatives putting at risk the internal market.
Finally, measures to ensure uniformity of classification of identical substances manufactured by different companies will enable SMEs to take advantage of classifications included in the inventory and not spend costs for classifying.
• Fundamental rights
The proposal respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union 30 .
Under Article 52 i of the Charter, any limitation on the exercise of the rights and freedoms recognised by this Charter must be provided for by law and respect the essence of those rights and freedoms. Subject to the principle of proportionality, limitations may be made only if they are necessary and if they genuinely meet objectives of general interest recognised by the Union or the need to protect the rights and freedoms of others.
This proposal strikes the right balance between the fundamental right of freedom to conduct a business and the fundamental right of property and other fundamental rights (environment, health, remedy). It has no impact on gender equality.
The limitation to the right of freedom to conduct a business and the right of property is limited to what is necessary to preserve the other above-mentioned fundamental rights and objectives of general interest in accordance with Article 52 i.
The proposal contributes to (i) the objective of a high level of environmental protection in accordance with the principle of sustainable development as laid down in Article 37 of the Charter; (ii) the right to life and the integrity of the person and its health as laid down in Articles 2, 3 and 35 of the Charter; and (iii) the right to consumer protection as laid down in Article 38.
It also contributes to the right to an effective remedy as laid down in Article 47, in relation to the protection of human health.
4. BUDGETARY IMPLICATIONS
This proposal does not have immediate budgetary implications. One of the retained measures needs to allocate 5 FTEs to the Agency. This will be considered in the on-going wider assessment on the reallocation of tasks to the Agency.
5. OTHER ELEMENTS
• Procedure for adoption
This proposal also includes amendments to Articles 23, 25 and 29 as well as to Annexes I, II, III, VIII for which the Commission is empowered under Article 53 i of the CLP Regulation, to adopt delegated acts in order to adapt them to technical and scientific progress 31 .
While the Commission is empowered to adopt a delegated act for the aforementioned amendments, other measures that form part of the same set of amendments pertain to Articles for which the Commission is required to make a legislative proposal via the ordinary legislative procedure. The amendments to labelling provisions are a good example of this aspect. To ensure the coherence of these measures, the Commission has decided to introduce all measures in this legislative proposal, i.e. amendments of essential elements together with amendments of certain non-essential elements of the CLP Regulation. This will ensure a transparent and effective discussion of the policy package and enable the synergies between complementary measures to manifest. Moreover, bundling all amendment proposals together will facilitate legal clarity for all involved. However, this has no bearing on Commission empowerment under Article 53 i of the CLP Regulation, which should be kept for future amendments.
On the other hand, the criteria for the new hazard classes ED, PBT, vPvB, PMT and vPvM can be introduced via a delegated act separately as they are self-standing. The timely adoption of the delegated act introducing new hazard classes will precede the negotiation process (and the final adoption of this proposal) and also facilitate the negotiation on introduction of these hazard classes into the UN Globally Harmonized System (GHS) of Classification and Labelling of Chemicals. The EU has submitted a proposal for new work on unaddressed hazard classes in the GHS work programme for 2023-2024 32 . This underlines the EU’s role as global front runner in the environment and health protection. It contributes to the CLP Regulation’s objective of protecting human health and the environment from the most hazardous substances, while also ensuring a well-functioning single market for chemicals. Lastly, adoption of the ED hazard classes by delegated act also responds to calls by the Council and the European Parliament for the Commission to take swift action on adopting criteria for endocrine disruptors. The European Parliament called on the Commission to ‘swiftly take all necessary action 33 to ensure a high level of protection of human health and the environment against EDs’ 34 . In its conclusions of June 2019, the Council also called for urgent action 35 . Moreover, the Council Conclusions of 15 March 2021 36 , which expressed explicit support for introducing the new hazard criteria, called for full implementation of the Chemicals Strategy for Sustainability ‘without undue delay’.
• Implementation plans and monitoring, evaluation and reporting arrangements
To monitor and evaluate the effectiveness of this proposal, the Commission is currently developing a framework – due by 2024 – of indicators monitoring the drivers and impacts of chemical pollution and measuring the effectiveness of chemicals legislation. The development involves the expertise of all relevant agencies, in particular the European Environment Agency and the European Chemicals Agency. This framework will be fully aligned to and complement the monitoring and outlook framework of the EU zero pollution action plan and the monitoring framework of the 8th environment action programme to 2030.
• Detailed explanation of the specific provisions of the proposal
The amendment of Article 1 i results into a clarification that the obligations under Article 45 to notify poison centres also cover certain distributors, i.e. relabellers, rebranders and distributors supplying in another Member State than the one in which the mixture was notified.
The amendment to Article 2 introduces a definition for multi-constituent substances and of acute toxicity estimates.
The amendment of Article 4(10) requires that there is a supplier established in the Union, which ensures that the substance or the mixture meets the requirements set out in the CLP Regulation when it is being placed on the market, including via distance sales. This provision will improve compliance with and enforcement of the CLP Regulation and will ensure a high level of protection of human health and the environment. In order to prevent situations where consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from the economic operators established outside the EU, the amendment of Article 4(10) specifies that the supplier in the EU which ensures that the substance or the mixture in question meets the requirements set out in the CLP Regulation acts in course of an industrial or professional activity.
The new Article 5(3) sets out that ‘multi-constituent substances’ shall, normally, be classified following the same classification, labelling, and packaging rules as mixtures and includes the identification and examination of available information on these ‘multi-constituent substances’.
Article 6(3) and Article 6 i are amended to extend to the new hazard classes regarding endocrine disruptors, PBT, vPvB, PMT and vPvM the classification provisions already in place for certain hazard classes, according to which the information on the substance included in the mixture is used to classify the mixture itself.
Amendments to Article 9(3) and i clarify the use of bridging principles in order to classify a mixture or ‘multi-constituent substance’, simultaneously when applying the weight of evidence approach using expert judgement.
Amendments to Article 10 require manufacturers, importers and downstream users to establish acute toxicity estimates that allow for the calculation of thresholds at or above which a substance or mixture is to be classified as acutely toxic. Where specific acute toxicity estimates exist for those hazard classes for which substances have a harmonised classification and labelling (entries in Table 3 of Part 3 of Annex VI to the CLP Regulation), acute toxicity estimates must not be set by manufacturers, importers or downstream users. Furthermore, application rules for concentration limits are clarified for cases in which the presence of a hazardous substance as an identified impurity, additive or individual constituent leads to the classification of a mixture.
Amendments to Article 23 and Section 1.3. of Annex I provide derogations from some labelling obligations for certain ammunition that are not articles and set out specific rules for the labelling of certain ammunition shot through firearms.
Furthermore, the obligation under Article 32(6) to include label elements that are resulting from requirements provided for in other EU acts is moved to Article 25. The obligation to include supplemental information on certain mixtures that containing classified substances in Article 25(6) is extended to also cover also certain mixtures which that contain non-classified substances that share the properties set out in Part 2 of Annex II to the CLP Regulation.
The amendments to Article 29 and Section 1.5 of Annex I set out specific labelling provisions for substances and mixtures in very small containers; where the container is so small that these obligations cannot be met, a reduction in the label elements is allowed according to specific rules. It also sets out specific provisions for labelling of chemicals sold in bulk to consumers. Furthermore, ammunition used by the military in combat zones is exempted from labelling requirements under certain conditions.
The amendment to Article 30 clarifies the timeframe for the obligation to update the label by setting a fixed deadline and by clearly defining the start of the transition periods.
The amendments to Article 31 i and (3) introduce obligatory formatting rules for labels, especially for fold-out labels.
Article 32(6) is deleted as the obligation to place label elements resulting from requirements provided for in other EU acts in the section for supplemental label information is moved to Article 25.
The newly introduced Articles 34a and 34b set out the rules on digital labelling. Only label elements that are not instrumental in protection of health and safety and the environment, and are not obligatory under GHS may be replaced by a digital label. The digital label must meet certain requirements. For example, it must be searchable, available in less than two clicks and not track any user data. The Commission should be empowered to adopt delegated acts in accordance with Article 53 i in order to adapt the labelling elements that may be provided digitally only to technical and scientific progress as well as to digital readiness.
The amendment to Article 36 adds the new hazard classes to be adopted via the delegated act (ED, PBT, vPvB, PMT, vPvM) to the list of hazards that are normally subject to harmonised classification and labelling.
The amendment of Article 37 mandates the Commission to initiate the harmonised classification and labelling procedure in addition to the right currently conferred on Member States competent authorities and manufacturers, importers and downstream users. In such a case, the dossiers would be developed either by the Agency or by the Authority. The possibility to initiate harmonised classification and labelling proposals for several substances at once is added by replacing the references to ‘substance’ by ‘substances’. It is clarified that the harmonised classification and labelling procedure under Article 37 can include acute toxicity estimates where appropriate. Paragraphs 7 and 8 are added to Article 37 to insert an obligation on the Commission to adopt delegated acts to amend Annex VI in order to include in Table 3 of Part 3 of that Annex substances that have been included in the candidate list as ED, PBT or vPvB under the REACH Regulation, and those that have not been approved under the Plant Protection Products Regulation and the Biocidal Products Regulation or those that have been approved because they fulfilled the conditions for derogation.
Article 38 is amended to adjust to the newly defined acute toxicity estimates.
The amendment to Article 40 i introduces and specifies the obligation to provide the Agency with the reasons for divergence from other classification entries for the same substance and to update notifications within 6 months after a decision to change the classification and labelling of a substance has been taken.
The amendment to Article 42 i sets out that the identity of the notifier must be made publicly available, subject to duly motivated confidentiality requests. If there are group notifications, only the identity of the notifier acting on behalf of the group members needs to be made publicly available.
The amendment to Article 45 obliges certain distributors to notify information on emergency health responses to appointed bodies where the latter would not have all the information required to carry out the tasks for which they are responsible, in particular in case of distribution across borders, or re-branding or re-labelling. This information could now also be shared with the Commission and with the Agency upon request for the purpose of statistical analysis and evaluating the need for risk management measures.
The amendment to Article 48 makes a distinction between advertisements and distance sales offers linked to the marketing and sale of hazardous chemicals. It provides that advertisements of hazardous substances and certain mixtures should contain, in addition to the hazard class, the hazard pictogram, the signal word and the hazard statements. The newly introduced Article 48a provides for requirement for distance sales offers to indicate the applicable labelling information.
Amending Article 50 provides for the possibility of designating the Agency as the appointed body to receive relevant information for emergency health responses under Article 45. It further tasks the Agency with ensuring the availability of appropriate tools to share information with national appointed authorities so they fulfil their other obligations under Article 45. Furthermore, it clarifies the Agency’s remit of providing competent authorities with tools to support CLP Regulation implementation and industry with tools to comply with the CLP Regulation.
Article 53 paragraph 1 is amended to empower the Commission to amend the new Article 34a on the content of digital labels by means of delegated acts. This is based on technical and scientific progress and the level of digital readiness among all population groups.It is further amended to oblige the Member States and the Commission to promote harmonisation of the criteria for classifying and labelling ED, PMT and vPvM substances at UN level, in the same way as their current obligation related to the criteria for classifying and labelling PBT and vPvB substances. The same obligation is introduced on the promotion of non-animal methods at the UN.
The amendment to Article 53c relates to the scope of the Commission’s obligation to adopt separate delegated acts in respect of each power delegated to it under the CLP Regulation. It aims to allow for the adoption of one single delegated act when it amends Part 1 and Part 2 together with Part 3 of Annex VI to the CLP Regulation triggered by the harmonised classification procedure of a particular substance or group of substances.
Part 1 of Annex I is amended to provide that supplemental labelling information under Article 25(3) may be provided in a digital format only. It will introduce formatting requirements for labels, specific labelling requirements for bulk sales as well as an exemption from labelling requirements for certain mixtures in small packaging and for certain ammunitions. Moreover, it clarifies a provision on the weight of evidence determination. The amendment to Part 5 of Annex II specifies a labelling exemption for ready-mixed cement and concrete in the wet state and sets out an exemption from the labelling obligations for sales of chemicals in bulk to consumers. It also sets specific packaging requirements for bulk products for sale at refill stations.
Amendments to Part A and Part B of Annex VIII extend the obligation to submit information to certain other suppliers, in addition to downstream users and importers, where appointed bodies would not have sufficient information to provide an adequate emergency health response. The amendments also define the term ‘composition conforming with a standard formula’ in the context of certain submission requirements for gypsum, ready-mixed concrete and cement. They introduce the obligation to provide the name and product description of the standard formula for the fuel in the submission and provide in certain cases for the obligation to submit information on components even if they are not always present. Furthermore, they clarify when submission updates are required, as well as ways to identify the mixture, submitter and contact point by means of their product identifier.