Explanatory Memorandum to COM(2007)355 - Classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 [SEC(2007) 853] [SEC(2007) 854] - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2007)355 - Classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No ... |
|---|---|
| source | COM(2007)355  |
| date | 27-06-2007 |
This proposal builds on existing chemicals legislation and establishes a new system on classification and labelling of hazardous substances and mixtures by implementing in the EU the international criteria agreed by the United Nation Economic and Social Council (UN ECOSOC) for the classification and labelling of hazardous substances and mixtures, called the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
Chemicals are manufactured and traded globally, and their hazards are the same around the world. Therefore the description of hazards should not differ between countries if the product is the same.
Enterprises will save costs if they do not have to assess hazard information for their chemicals against different sets of criteria.
If the same criteria are used to identify the hazards of chemicals and the same labelling is used to describe them, the level of protection of human health and the environment becomes more consistent, transparent and comparable throughout the world. Professional users of chemicals and consumers all over the world benefit from such a harmonisation.
In December 2002, the GHS was agreed by the UN Committee of Experts on the Transport of Dangerous Goods and the Globally Harmonized System of Classification and Labelling of Chemicals (CETDG/GHS) i. It was formally adopted by UN ECOSOC i in July 2003 and revised i in 2005. In its Plan of Implementation, adopted in Johannesburg on 4 September 2002, the World Summit on Sustainable Development encouraged countries to implement the GHS as soon as possible, to have the system fully operational by 2008.
Besides participating in the UN work to develop the GHS, the Commission announced its aim to propose the implementation of the GHS into Community legislation on several occasions, e.g. in the 2001 White Paper ‘Strategy for a future Chemicals Policy’[4], and the Explanatory Memorandum to the amendment to Directive 67/548/EC i, adopted at the same time as the REACH proposal. The present proposal fulfils that commitment.
The current EU classification and labelling system for chemicals is set out in three key instruments:
- the Dangerous Substances Directive (67/548/EEC) i;
- the Dangerous Preparations Directive (1999/45/EC) i;
- the Safety Data Sheet Directive (91/155/EEC) i.
They pursue internal market objectives, i.e. the establishment of a Single Market in chemicals. The Directives are based on a high level of protection concerning health, safety, environmental and consumer protection (Article 95 i EC Treaty).
The first two Directives set out rules on the classification, packaging and labelling of dangerous substances and preparations. The Safety Data Sheet Directive ensures that suppliers of substances and preparations provide information about the hazards of their chemicals and guidance on safe use to professional customers. These provisions have been taken up in REACH i.
The current EU system and the GHS are conceptually similar. Both cover classification, packaging and hazard communication through labelling and safety data sheets. The GHS is a common approach that provides criteria for harmonised classification and hazard communication for different target audiences, including consumers, workers and emergency responders, and in transport. Therefore, it includes a “building block” approach to enable countries to adopt the system having regard to the various target audiences in different legal areas. As the GHS provides a common system of the classification and labelling for transport, supply and use, this proposal aims to ensure coherence with EU transport legislation, where relevant. EU transport legislation will incorporate relevant GHS criteria by 2007 and 2009, in line with the timetable for adoption of the UNECE Model Regulation.
This proposal addresses supply and use of chemicals and, therefore, the main target audience are workers and consumers, as is the case for the current EU system.
Experts have identified the differences between the current EU system for supply and use and the GHS system i. The Commission has based this proposal on their work. The number of classified substances resulting from the application of the new system is estimated to be approximately the same as under the current system.
Due to changes of cut-off values and calculation methods, more preparations – now called mixtures - will probably be classified under the new system. The application of the new criteria may result in a different classification compared to the current one.
As safety data sheets are the main tool for communication under the REACH Regulation, the provisions on safety data sheets remain there.
Two UN Expert Sub-Committees keep the technical aspects regarding health and environmental hazards and physical hazards of the GHS up-to-date. The Committee of the Experts on the Transport of Dangerous Goods and the Globally Harmonised System of Classification and Labelling of Chemicals endorses recommendations of the sub-committees and channels these to the UN ECOSOC, which will adopt revisions of the GHS on a biannual basis i.
Classification of substances and preparations triggers other obligations in EU legislation, referred to as downstream legislation.
The Commission services have assessed the potential effects of the implementation of the GHS criteria on downstream legislation. Their analysis concludes that effects are either minimal or can be minimised by appropriate changes to particular downstream acts. This draft Regulation includes such changes to Regulation (EC) No 1907/2006. For the Seveso II Directive i, where the implementation of GHS is expected to have a substantial impact, necessary measures have to be introduced in a separate amendment. Other separate amendments implementing the GHS for other EU downstream acts will be part of an upcoming Commission proposal.
During the stakeholder consultation, some parties mentioned the lack of analysis of national legislation referring to EU classification. However, the assessment of the effects on national legislation is within the competence of Member States. It may be worthwhile for them to analyse national downstream acts along the lines of the study on EU legislation.
Public stakeholder consultation
Internet consultation
The Commission launched a stakeholder consultation on the internet from 21 August to 21 October 2006. All responses were published on the Internet. Some 370 contributions were received. 82% were sent by industry - companies or associations; of the 254 company responses, 45% came from enterprises with less than 250 employees. 10 NGOs and one trade union responded.
18 Member State governments and/or public authorities sent comments. Non-EU public authorities (Iceland, Norway, Switzerland, Romania) gave input as well. No international organisation sent comments. 97% of the responses supported the implementation of the GHS in the EU and 96% of these by means of a Regulation. Overall the draft proposals of the Commission services were well appreciated by Member State authorities and industry.
Scope: 59% supported not changing the level of protection in comparison with the current EU system, except to be consistent with transport legislation or the GHS. 5% had no opinion, including most of the NGOs. 36% favoured a different approach. Of these, one group (governmental bodies in Denmark, Sweden, Norway, Iceland), wanted to go beyond the scope of the current system; the second group (associations and companies) proposed to include all GHS categories, but not to include the 'EU left-overs' not yet part of the GHS.
The majority of respondents supported maintaining the current level of protection and the Commission has not changed the proposal in this regard. However, flammable gases Cat. 2 was included as requested by some Member States and industry.
Transitional period: No specific comments were made on the two stage structure (substances then mixtures) of the transitional period. A clear majority of respondents (around 60%) supported a three-year transition period for substances after entry into force of REACH. This would require all enterprises to register the first wave of phase-in substances and notify the classification and labelling of their substances to the Chemicals Agency. Fixing the transition period for substances in line with the relevant period in REACH avoids double work as confirmed by the impact assessment. Some stakeholders preferred a longer deadline allowing to postpone the work until after the last registration deadline in REACH.
For mixtures, almost half of the responses supported the 5 year option. Nearly equal numbers of the remaining responses preferred either a longer period or a shorter period. Industry responses were divided, with significant support for 5 years for mixtures, sometimes coupled with a demand for a longer period for substances. Member States looked for a shorter period, typically 3 years.
The Commission therefore proposes a transition period for substances of three and a half years after the entry into force of REACH. As the length of the transition period for mixtures is less evident and the impact assessment does not show clear enough results to give preference for either four or five years, a transition period of 4.5 years is proposed.
Specific comments : Around 15% of the respondents provided specific comments.
A large majority of these comments from industry and Member States were technical, seeking more clarity and consistency. Issues repeatedly pointed out are:
- align the definition of mixtures with that of REACH;
- describe the general obligations of Article 4 to classify, label and package more clearly;
- allow the use of an international chemical name beside the name of the IUPAC Nomenclature, limit the names on a label for a mixture in line with the requirements of the current legislation, include a provision to allow the use of shorter names;
- clarify that the content of the publicly accessible part of the classification and labelling inventory is consistent with Article 119 of the REACH Regulation;
- include the specific rule of current legislation with regard to advertising mixtures;
- specify more clearly the body responsible for receiving information relating to health in line with the current legislation;
- reconsider the provision for small packaging to counterbalance the bigger space demand of the GHS label information.
Another request from the majority of Member States and downstream users was the 'translation' of the current Annex I of Directive 67/548/EEC (list of harmonised classification and labelling of substances) into the new Annex VI, so as to maintain the results of efforts to build up Annex I.
All these points were considered and taken up in the revised proposal.
The impact assessment made use of the impact assessment consultant reports prepared by RPA and London Economics as well as the responses to the Internet Consultation. The responses from companies on costs led to further efforts to quantify significant cost items. The overall analysis demonstrates that the implementation costs need to be kept in check so as to arrive at the net benefits of the GHS in the foreseeable future.
The GHS was developed by international organisations, with participation of various stakeholders. Similarly, in the EU there have been continuous technical discussions with Member States and other stakeholders over the past years. Following the publication of the White Paper “Strategy for a future Chemicals Policy”, the Commission consulted widely with experts. The results of the technical working group on classification and labelling convened by the Commission in preparation for REACH i have been taken into account in drafting this proposal . Further studies were carried out i and an informal stakeholder discussion on the implementation of the GHS in the EU took place on 18 November 2005.
Contents
- Legal elements of the proposal
- REASONS AND OBJECTIVES
- Global Context
- EU Context
- Current EU System and GHS
- Future Development
- Coherence with other policies
- RESULTS OF PUBLIC CONSULTATIONS AND IMPACT ASSESSMENTS
- Issues raised and how they are addressed
- Impact assessments
- Collection and use of expertise
- Legal basis
- S ubsidiarity and proportionality
- Proportionality
- Choice of legal instrument
- INTRODUCTION TO THE PROPOSAL
- 1. REASONS AND OBJECTIVES
- 2. GENERAL ISSUES
- 3. LABELLING
- 4. PACKAGING
- 5. HARMONISATION OF CLASSIFICATION AND LABELLING OF SUBSTANCES; THE CLASSIFICATION AND LABELLING INVENTORY
- 5.1. Establishing harmonised classification and labelling of substances
- 5.2. Notification to the Agency and establishing the classification and labelling inventory
- 6. COMPETENT AUTHORITIES AND ENFORCEMENT
- 7. COMMON AND FINAL PROVISIONS
- 8. ANNEXES
- Annex II
- Annex III
- Annex IV
- Annex V
- Annex VI
- Annex VII
Article 95 of the EC Treaty is the appropriate legal basis. The aim is to ensure a level playing field for all suppliers of substances and mixtures in the internal market, as well as a high level of protection of health, safety, environment and consumers.
This legal basis ensures that the requirements for substances and mixtures are harmonised and that substances and mixtures complying with them can move freely throughout the internal market. This rewards the efforts required from economic actors to reclassify substances and mixtures.
Moreover, Article 95 i requires a high level of health, safety, environmental and consumer protection. This Regulation falls within this remit.
Subsidiarity
Existing Directives on the classification and labelling of substances and preparations already set forth an extensive system. The new Regulation will replace the existing Directives. Classification and labelling provisions need to be exactly the same in all Member States, and should therefore be regulated at Community level.
The criteria for the classification of substances and mixtures as hazardous, including the building block approach that invites the legislator to choose the appropriate hazard classes and categories, have been developed at international level. To ensure proportionality, the Commission selected those hazard classes and categories which are comparable with existing legislation. Therefore, this proposal does not include certain categories not part of current EU legislation. Elements which are part of current EU legislation, but have not yet been included in the GHS, are also part of this proposal, e.g. “ozone depletion”.
To be consistent with the GHS, those elements which were only subject to additional labelling requirements under the current EU system, but which are now part of the GHS classification system, will now have to be classified. However, for those hazard classes or categories which are added in comparison to the current EU system, no obligations should be triggered under other legislation, e.g. REACH. For consistency with transport legislation, this proposal incorporates some hazard classes or categories which are not included in current EU legislation for supply and use, but are part of the existing EU transport system or will be implemented in transport legislation.
Therefore this proposal for a Regulation is proportionate.
The choice of a Regulation is justified, as it will lead to the direct application of the rules throughout the Community. It replaces 2 existing and dated Directives (with 10 Amendments and 30 Adaptations to Technical Progress). It also contains mainly technical details agreed at UN level, which it is not appropriate to change, as this would defeat the purpose of global harmonisation. In the area of technical legislation, Regulations are a widely used technique that has already met with the support of Member States in other areas i. It is even more justified in a Community of 27 Member States that will certainly benefit from homogeneous and directly applicable rules throughout its territory.
THIS REGULATION SETS OUT RULES FOR THE CLASSIFICATION OF SUBSTANCES AND MIXTURES AS HAZARDOUS AND FOR THE LABELLING AND PACKAGING OF SUCH HAZARDOUS SUBSTANCES AND MIXTURES.
The objective of this Regulation is to ensure a high level of protection of human health and the environment, while guaranteeing the free movement of substances and mixtures within the internal market. To this end, the Regulation takes a fivefold approach based on the GHS.
First, it harmonises the classification, labelling and packaging rules for substances and mixtures. Second and third, it obliges enterprises to classify their substances and mixtures themselves and to notify the classifications. Fourth, it establishes a harmonised list of substances classified at Community level in Annex VI. Finally, it establishes a classification and labelling inventory, made up of all notifications and harmonised classifications referred to above.
The Regulation applies to substances and mixtures. However, since the physical hazards of substances or mixtures are to some extent influenced by the way in which they are released, the Regulation also covers release by aerosols through a specific hazard class. Radioactive substances are excluded from the scope, as they are covered by other rules. Substances and mixtures subject to customs supervision are also excluded, subject to certain conditions, as they are not supplied in the EU. Non-isolated intermediates are not included for the same reason. Substances and mixtures for scientific research and development not placed on the market are also excluded when used under controlled conditions minimising exposure.
The essential terms are defined. Following the GHS, the term “preparation” is replaced by “mixture”.
Annex I lists the hazard classes of the GHS, as well as the relevant hazard categories and criteria. If a substance or a mixture fulfils the criteria for any hazard class, it is hazardous. The Commission is empowered to update Annex I and to include new hazard classes agreed at UN level. The concept of “dangerous” is also laid down, in order to allow minimising effects on downstream legislation.
Before a substance or mixture is marketed, the supplier must classify it. This means he must identify and describe its hazards, evaluate this information and compare it with the criteria of the Regulation. Suppliers may define other concentration limits which differ from the generic concentration limits in justified cases, unless Annex VI contains specific concentration limits. However, where harmonised classifications for a hazard class or differentiation within a hazard class are included in this Regulation for a substance, the supplier must classify in accordance with that entry, and must not deviate from it on the basis of available information.
Distributors must ensure that they pass on the relevant information, either by keeping the labels on the substances or mixtures they receive or by applying the rules of this Regulation themselves.
The procedure for identifying information relevant for hazard classification is described. No new testing needs to be done for the purpose of classification only. Thus, available information from public sources and information generated under other EU legislation like REACH, the transport, biocides or plant protection product legislation, may be used.
If the supplier generates new information, certain quality conditions must be met, to ensure that classification is based on sound data. International standards are accepted as well as data that fulfil the requirements of REACH or other legislation. Testing on animals must be avoided wherever possible and alternative methods always must be considered first. Animal tests must comply with the relevant Directive i. Testing on humans is not permitted; only available experience on effects on humans may be used.
For mixtures, there is a general obligation to use available test data on the mixtures themselves, except for mixtures containing substances with e.g. CMR properties. For the latter, the classification of the mixtures is normally based on the information on those substances. If no test data are available on the mixtures themselves, Annex I specifies “bridging principles”, which enable suppliers to derive a sound classification of mixtures. If the available information is not sufficient for the application of those principles, the individual chapters of Annex I specify what needs to be done.
The identified relevant information needs to be evaluated for the purpose of classification, by comparing it with the criteria in Annex I.
The classification of mixtures must take account of all available information about potential occurrence of synergistic and antagonistic effects among the ingredients. Cut-off values ensure that the system is workable and proportionate. A new hazard evaluation is required when the composition of a mixture is changed outside specified limits, unless it is evident that the change has no effect on the classification.
Agreed classifications must be respected, unless the supplier has sufficient evidence to justify a different classification.
The label elements from the GHS are specified, i.e. the name, address and telephone number of the supplier, product identifiers, hazard pictograms, signal words, hazard statements and precautionary statements. To maintain the level of protection of current EU law, supplemental information on hazards not yet included in the GHS must also be mentioned. Furthermore, as is the case today, the nominal quantity in the package, as placed on the market to the general public, has to be indicated. To protect confidential business information, it is possible, as is the case today, to apply for permission to use a name that does not reveal the substance’s chemical identity. The Agency established by the REACH Regulation will decide on such applications.
Principles of precedence for labelling are specified..
The supplier has to update the label after changes to the classification, unless the labels are part of an approval decision concerning a biocide or a plant protection product. In the latter case, the applicable special legislation has to be complied with.
To ensure that customers notice hazard information, there are rules on the colours and format of labels and on the location of information on labels.
To reduce the burden on enterprises and to avoid the duplication of transport labels, there are provisions determining which labels to use in case of inner and outer packages.
Safety measures for containers and other packages are set out.
5. HARMONISATION OF CLASSIFICATION AND LABELLING OF SUBSTANCES; THE CLASSIFICATION AND LABELLING INVENTORY
The provisions of Title XI of the REACH Regulation are moved to this Regulation, with certain technical changes.
For specific hazard classes harmonised classifications can be included in Annex VI, while harmonisation of other hazard classes is possible if there is a need for Community wide action. The applicable procedure is set out, ensuring that expert opinion is taken into account and that stakeholders may comment.
Specific information must be provided for inclusion of a substance in the inventory. As classification and labelling data are part of the information needed for registration under REACH, there is no need to notify the information if a registration has been submitted.
If the classification is changed, as a result of REACH or otherwise, the entry must be updated. It is anticipated that for some substances the classifications will vary. Over time, it is expected that notifiers and registrants will agree on a single entry.
Where the entries differ, enterprises must make every effort to agree a single entry. This reflects the principle of industry self-responsibility and enables authorities to focus resources on substances with properties of very high concern.
The information to be included in the inventory is set out. It will be widely available as a source of information on substances and will encourage industry to come to agreed entries.
Member States must to appoint the authorities for the application and enforcement of this Regulation. Good cooperation between all competent authorities is essential.
To bundle information on human health, as under current legislation, one body per Member State is responsible for receiving health-related information.
Member States are to take all measures necessary to ensure correct application of this Regulation. To enhance the exchange of practical experience, the Agency’s Forum established by the REACH Regulation shall also exchange enforcement information under this Regulation.
Finally, Member States have to establish proportionate sanctions for non-compliance.
There are special rules on advertising, to avoid misleading customers.
To be able to retrace their decisions taken in applying this Regulation, suppliers must keep the relevant information, together with any information they are required to keep under the REACH Regulation. Authorities may request this information.
Similar to its role under REACH, the Agency’s Secretariat is to prepare guidance and tools for industry as well as guidance for authorities.
Free movement of substances and mixtures that comply with the provisions of the Regulation is guaranteed, while Member States are enabled to address risks to human health and the environment by appropriate provisional measures.
The Commission is empowered to adapt all annexes as well as a number of Articles to technical progress through a Committee procedure, as they relate to scientific and technical matters and do not touch the fundamental rules of the Regulation. The Committee established by the REACH Regulation shall also assist the Commission under this Regulation. The regulatory procedure with scrutiny has to be applied for adaptations to technical progress. For confirmation or refusal of the provisional measures taken under the safeguard clause and for fees, the ordinary regulatory procedure will be applied, as such decisions do not involve changes to the Regulation.
The findings of the analysis of the potential effects of the GHS Regulation on EU downstream legislation are reflected in the proposal. Directives 67/548/EEC and 1999/45/EC are replaced by this Regulation at the end of the last transitional period set out. References in Community legislation to those Directives and their provisions and classifications will be replaced by references to this Regulation through separate acts. The Regulation specifies which hazard classes or categories trigger obligations under REACH; by doing so, it leaves the current scope of REACH intact.
The obligations under this Regulation apply to the supply of substances. Not all duties apply when the Regulation first enters into force. As the classification of mixtures depends on the classification of substances, the new criteria will have to be applied first to substances, before they are applied to mixtures.
The deadline for mixtures strikes a balance between avoiding too much confusion from the use of a dual system during the transitional period and the need to allow enterprises sufficient time to manage the new workload arising from reclassifying substances and mixtures that have already been on the market in addition to those that are newly supplied.
For the transitional period, maximum flexibility is given to enterprises: they are free to use either of the two systems. This will encourage enterprises to align to the new system in the most efficient way.
For some hazard classes and hazard categories, during the transitional period the table of equivalence which is provided may serve as a first orientation for the results that might follow from the application of the new criteria.
Guidance provided to assist operators in fulfilling the obligations under this Regulation will include a table with references to the specific categories of danger and risk phrases according to Directive 67/548/EEC which should be read as references to specific hazard classes, differentiations and hazard categories in this Regulation.
Annex I
Annex I includes a General Introduction (part 1), the hazard classes and criteria for physical, health and environmental hazards (parts 2, 3 and 4) replacing Annex VI of Directive 67/548/EEC, except for ozone depletion, which is placed in part 5.
Part 1 includes the extra labelling provisions from Annex VI to Directive 67/548/EEC not yet covered by the GHS; part 2 contains special rules for labelling certain substances or mixtures, mainly from Annex V to Directive 1999/45/EC. Part 3 provides for child-proof fastenings and tactile warnings retained from the current EU system. Part 4 contains a special labelling rule for plant protection products.
The list of hazard statements is similar to Annex III of Directive 67/548/EEC. Additional hazard statements are required for hazards not currently part of the GHS; thus, R-phrases from the current EU scheme were added as “EUH-statements”.
Rules for applying precautionary statements are given. The list of precautionary statements is similar to Annex IV of Directive 67/548/EEC.
This reproduces the GHS hazard pictograms and is similar to Annex II of Directive 67/548/EEC.
Part 3 is a list of substances with harmonised classifications for specific hazard class(es) or differentiation(s) and hazard category/ies. As authorities should focus on substances of the highest concern, mainly substances classified for carcinogenicity, germ cell mutagenicity or reproductive toxicity Cat. 1A or 1B, and for respiratory sensitisation will be added, but other effects can be added if justified. Table 3.1 of the Annex includes the entries in Annex I of Directive 67/548/EEC, adapted where necessary to the GHS classification criteria, Table 3.2 contains the unadapted entries taken over from Annex I of Directive 67/548/EEC.
This includes ”translation” tables for suppliers of substances and mixtures already evaluated under the current rules for those hazard categories where a simple equivalence exists.
These tables provide an option for suppliers to fulfil their new obligations without having to make an ab initio reclassification of their currently self-classified substances and mixtures. Should a supplier choose not to use the table, he must re-evaluate the substance or mixture using the criteria laid down in parts 2 to 5 of Annex I.