5 Safer use of chemicals in Europe
Norway shares the EU rules on chemicals, with the exception of pesticides, which are governed by separate, more restrictive Norwegian legislation. Thus, EU chemicals legislation affects Norway directly. The EU is the world’s largest producer of chemicals, releases from the EU area are transported northwards by air and ocean currents and therefore have an impact in Norway as well. Norway will therefore call for and play a leading role in efforts to provide a high level of protection for health and the environment in the development of the new EU chemicals legislation REACH (Registration, Evaluation and Authorisation of CHemicals). As this legislation is implemented, Norway will play an active part in evaluation and regulation of priority substances at European level.
The Government will
play a part in making the new EU chemicals legislation REACH as ambitious as possible in order to protect health and the environment, including the working environment, by means of:
strict regulation of the most dangerous substances throughout the EEA
providing information on chemicals that are on the market through REACH
giving industry a clear responsibility for all chemicals that are on the market
consider whether to request derogations from the provisions of REACH for Norway if this is necessary to achieve the target of eliminating releases and use of priority ecological toxins by 2020, or if the provisions of REACH will in any other way reduce the level of protection of health and the environment in Norway
take steps to ensure that Norway evaluates about 5–15 priority substances and proposes their regulation under REACH.
5.1 REACH – a new European chemicals policy
Because Norway shares the EU legislation on chemicals, it has limited freedom of action to implement a more ambitious chemicals policy than the EU, particularly if this affects trade in products. Rules on prior notification, risk assessment, the classification and labelling of chemicals, and restrictions or prohibitions on the use of some substances have been laid down in a number of EU directives and regulations. Through the development of its legislation, the EU has made a great deal of progress in regulating chemicals. Most of the derogations Norway was granted when the EEA Agreement was adopted have ceased to apply because the level of protection under EU legislation has been raised to the level Norway considers appropriate. Nevertheless, both environmental organisations and the business sector have strongly criticised the legislation, particularly because it has not made it possible to assess and regulate the great majority of the substances that exist on the EU market.
Figure 5.1 The new EU chemicals legislation is intended to give industry more responsibility for obtaining and providing information about chemicals
Photo: Marianne Otterdahl-Jensen
Textbox 5.1 What is REACH?
In autumn 2003, the European Commission presented a proposal for a new regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals, abbreviated to REACH. It is intended to improve the protection of human health and the environment through the better and earlier identification of the properties of chemical substances, and to reduce the use of the most hazardous substances. It will also give industry in the EU and EFTA greater responsibility for obtaining and providing information on chemicals, preparing chemical safety reports, managing risks, and ensuring safe use of chemicals. At the same time, the competitive position of industry in the EU/EFTA is to be maintained and enhanced.
The main elements of REACH are:
Registration of chemicals. This applies to substances on their own and in preparations, and in many cases to substances in articles. Manufacturers and importers are required to register all substances produced or imported in quantities higher than 1 tonne per year and to submit information on their toxicological and ecotoxicological properties and uses. A chemical safety assessment is also required for substances. More information is required for substances that are marketed in large volumes, while the requirements are less detailed for substances that are only marketed in low volumes, i.e. 1 – 10 tonnes. Companies must submit a registration dossier to a new independent body, the European Chemicals Agency. Substances that are already on the market are to be registered gradually over an 11-year period. Those that are marketed in large volumes or are hazardous to health or the environment are to be registered first, over a three-year period.
Evaluation of all substances registered in quantities of 100 tonnes or more per year. In addition, national authorities, for example the Norwegian authorities, may suggest evaluation of other substances if they are suspected of posing a serious risk to health and/or the environment. The authorities will evaluate whether more data are needed, for example further testing, information on exposure, and whether follow-up and action is needed.
Authorisation of substances of very high concern, to ensure that they are only used if the authorities have expressly approved this. Authorisation will be required for:
substances that are carcinogenic, mutagenic or toxic to reproduction (CMRs)
substances with persistent, bioaccumulative and toxic properties (PBTs) and substances that are very persistent and/or very bioaccumulative (vPvBs), endocrine disruptors, and substances that give rise to an equivalent level of concern
The EU Commission will grant authorisation for a limited period, and will take into account whether safer alternatives exist. If authorisation is not granted for specific areas of use, these uses will be illegal throughout the EEA.
Restriction: this procedure includes prohibition and restrictions on use, and is a safety net to supplement the authorisation system. The use of substances that pose a substantial risk to health and/or the environment may be banned altogether, or specific uses prohibited, if the risks associated with such use are not under adequate control. Current prohibitions and restrictions on the use of specific substances will be continued under REACH, and it will be possible to include new substances.
Establishment of the European Chemicals Agency, a new independent body, which is to be based in Helsinki.
A new policy is needed because the EU and EEA chemicals legislation has not reduced public concerns about the use and releases of dangerous chemicals. At present, the responsibility for proving that that there is a risk to health and/or the environment rests with the public authorities. The business sector has too little of the responsibility. Only about 70 substances have been dealt with under the risk assessment programme that was established in 1993, which demonstrates the lack of progress under current legislation. The use and releases of chemicals are being permitted today even though the long-term impacts of most substances are not known. Stricter legislation can thus provide major benefits by giving better protection of the environment, consumers and workers.
Textbox 5.2 Application of the precautionary principle in Europe
The EU supports application of the precautionary principle internationally. On the basis of the 1992 Maastricht Treaty and further elaboration in the 2000 Treaty of Nice, the precautionary principle has become an important element of EU legislation.
In 2000, the European Commission published a communication establishing guidelines for applying the precautionary principle, after identifying a need for input to the international debate on the precautionary principle and to the debate on how it should be applied within the EU. The Commission pointed out that the precautionary principle is particularly relevant to the management of risk where there is an element of scientific uncertainty. It also noted that measures based on the precautionary principle must meet criteria of non-discrimination and proportionality, that the potential benefits and costs of taking action must be examined, and that measures should be reviewed periodically after attempts to reduce the scientific uncertainty that was the basis for regulation or action. The EU will use the same guidelines when evaluating any Norwegian regulatory measures based on the precautionary principle.
Discussions on the REACH regulation in the EU’s political bodies have involved a tug-of-war between health and environmental concerns and business interests. During the first reading in autumn 2005, compromises were adopted by the Council and the European Parliament, resulting in even weaker requirements for the registration of substances that are only marketed in small quantities. At the same time, the Parliament adopted a number of ambitious elements that are in line with Norway’s positions, such as steps to strengthen the authorisation system. These included a provision that authorisation may not be granted if less harmful alternatives exist (obligatory substitution). The Parliament also wished to introduce a general duty of care in the legislation. During the second reading in autumn 2006, the European Parliament and the Council reached agreement on these issues, making it possible for REACH to be adopted by the end of the year and to enter into force in summer 2007.
What changes will REACH introduce?
Some EU acts of legislation, which are also part of current Norwegian legislation, will be repealed when the REACH legislation enters into force, so that extensive amendments to Norwegian legislation will be required. This will apply to the regulations concerning:
notification of new substances
evaluation and control of the risks of existing substances
restrictions on the marketing and use of dangerous substances and preparations
compilation and distribution of safety data sheets for dangerous chemicals.
The first and second of these will be replaced by REACH, while the third and fourth will be incorporated into the new legislation.
Figure 5.2 Under the EEA Agreement, Norway shares the EU legislation on chemicals
Separate legislation on the classification and labelling of chemicals will be retained. The EU will introduce the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in its new consolidated legislation for classification and labelling of dangerous chemicals. However, certain adaptations will be made to bring these rules into line with REACH by giving industry a clearer responsibility for classification and labelling of chemicals. The existing working environment legislation will continue to apply. Substances used in cosmetics and food packaging are to be registered with the European Chemicals Agency, but the chemical safety reports for such substances will only be required to include an environmental hazard assessment. The authorisation and restriction procedures will apply to PBT substances in cosmetics and food packaging, which is a clear improvement over today’s situation. Pesticides are already regulated by other legislation, and will not come within the scope of REACH.
The Government presumes that REACH will also apply to the petroleum industry on the Norwegian continental shelf, in the same way as other acts of legislation that are currently in force, for example the regulations on prior notification of new substances, classification and labelling of dangerous chemicals, and safety data sheets.
Why does the Government consider REACH to be important?
The Government has been advocating reversal of the burden of proof in chemicals legislation, so that industry rather than the authorities is made responsible for demonstrating that the chemicals used are safe. The proposed new EU chemicals legislation is an important step in the right direction, since it gives industry the responsibility for documenting the safety of the chemicals that they place on the market. Documentation is to be a condition for market access – «no data, no market».
Long-range transport of pollution carries ecological toxins to Norway and the Arctic. Regulatory measures in the EU are therefore of direct importance for pollution levels in Norway.
Norway has been advocating the highest possible protection level for health and the environment. Norway has sent comments at several stages during the preparation of the draft legislation, and the Government has several times urged the EU to ensure that REACH is as ambitious as possible in order to protect health and the environment, including the working environment. Norway considers the opportunity to take part in the activities of the new European Chemicals Agency that is being established in Helsinki to be particularly important. We have found it very useful to take part in cooperation with EU experts because this provides opportunities for the exchange of information and expert opinions on hazardous substances. Participation in the European Chemicals Agency will be an important means of continuing such cooperation under the REACH legislation.
The most important input the Government has provided during the development of REACH can be summarised as follows:
1. Substances of very high concern must be strictly regulated within the EEA
REACH must become an instrument for eliminating the use of the substances of very high concern, not for administering their continued use.
Authorisation to use substances of very high concern should not normally be granted if safer alternatives exist on the market (the substitution principle).
In cases where use of substances of very high concern is authorised, users of the products in question should be given clear information about this, for example by means of labelling.
In the Government’s view, both the EU and Norway should have ambitious goals for eliminating the use and releases of substances of very high concern, and the burden of proof should be reversed in chemicals legislation, so that industry is made responsible for documenting that chemical products are safe to use. Norway therefore considers that the authorisation procedure must be a tool for achieving these goals. Strict requirements relating to substitution are necessary to avoid authorisation being given for continued use of substances of very high concern if safer alternatives exist. The Government views the substitution principle as an essential part of the basis for this legislation, and has communicated this view to the EU on several occasions.
2. REACH must ensure the provision of information on all chemicals on the market
Basic information must be provided for all substances.
More information should be required for substances that are suspected of meeting the criteria for being «of very high concern», the substances that are most hazardous to health, and other substances whose use is expected to involve a high level of risk.
In the Government’s view, REACH should be used to deal with the problems related to the general lack of knowledge about chemicals. This means that there must not be exemptions from requirements to provide adequate information for large numbers of chemicals. However, it is also important to give highest priority to obtaining adequate information on the most hazardous substances and substances whose use is likely to involve a high level of risk on the basis of current knowledge.
3. Industry must be made clearly responsible for all chemicals on the market
A general duty of care should be introduced in the new legislation, to make clear the fundamental responsibility of industry for substances and products on the market.
In the Government’s view, a general duty of care should be laid down in REACH in addition to the more specific requirements it sets out. This should be formulated in such a way that it also reflects the substitution principle, thus clarifying the fundamental responsibility of industry for ensuring the safety of all chemical substances. This is particularly important since the obligatory information requirements are less stringent for low-volume substances. Another important point for Norway is that is should not be necessary to amend the Product Control Act to make the duty of care less stringent as regards chemicals.
Final procedures and the EEA Agreement
REACH will raise the level of protection for health and the environment in Norway by reducing the exposure of people and the environment to hazardous substances from products and processes, and thus reducing health and environmental damage. Reduction of long-range transport of pollution from the EU to Norway will also be important. These benefits will be felt particularly as a result of the generation of more basic knowledge about chemicals through REACH. Impact assessments in the EU and Norway have shown that the benefits of the proposed REACH legislation for health and the environment will far outweigh the costs for the business sector.
During the second reading of the proposed legislation, Norway focused on influencing the result to ensure a high level of protection for health and the environment. At the time of writing, it seems likely that REACH will be adopted by the EU before the end of 2006. Once this has happened, Norway will assess whether there is a need to request derogations through adaptations to the EEA Agreement. This may be appropriate if form of regulation for substances of very high concern is such that it will prevent Norway from achieving its own targets, or if it will be difficult to maintain the current statutory duty of care as regards substances and products.
Opportunities for Norway to influence developments
The Government’s considers that a high level of protection throughout the EEA is in the interests of the Norwegian business sector. The Norwegian authorities should make full use of the opportunities offered by REACH. Under REACH, national authorities may evaluate priority substances and put forward proposals for regulation or authorisation. This means that Norway can make an active contribution to regulation at European level of the substances it has identified as priority ecological toxins. The Government intends Norway to be involved in evaluation, risk assessment and proposals for regulation of priority substances throughout the 11-year implementation period, so that 5 – 15 substances are under consideration at any time. The main focus should be on substances that are on the Government’s priority list and included in the target of continually reducing releases and use of substances that pose a serious threat to health or the environment with a view to eliminating them within one generation. This will require considerable expansion of Norway’s efforts.