The registrant is obliged to register substances as such, not preparations, but all the substances in a preparation. This includes substances in articles if the chemical(s) is (are) intended to be released under normal or reasonably foreseeable conditions of use.
REACh definition (short form):
Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process.
Preparation: means a mixture or solution composed of two or more substances.
Article: means an object which during production is given a special shape, surface or design which determines its function.
REACh regulation (EC) No 1907/2006 and directive 2006/121/EC amending directive 67/548/EEC were published in the official journal on December 30, 2006, exceeding more than eight hundred pages. The new regulation aims to improve the protection of human health and the environment while maintaining competitiveness and enhancing the innovative capability of the EU chemicals industry.
This EU directive and the regulations do not only affect the 27 EU member nations. The EU standard could present trade barriers and impact thousands of businesses around the world that are directly or indirectly linked to the EU’s substantial share in the world market through international trade.
Twenty minutes are too short a time to explain REACh and its global waves. Therefore, I will remind you of Einstein’s theorem: Explain it as easily as possible but not easier.
The EU chemical legislation
The current EU chemicals legislation distinguishes between so-called ‘existing’ and ‘new’ chemicals based on the cut-off date of 1981. All chemicals that were reported as being on the European Community market between January 1, 1971 and September 18, 1981, listed in the European INventory of Existing Commercial Chemical Substances (EINECS) are called ‘existing’ chemicals. In 1981, they numbered more than 100,000 different substances.
Chemicals introduced to the market after 1981 are termed ‘new’ chemicals and published in the European LIst of Notified Chemical Substances (ELINCS). The current ELINCS contains 4,381 chemicals. While ‘new’ chemicals have to be tested before they are placed on the market, there are no such provisions for ‘existing’ chemicals. Thus, although some information exists on the properties and uses of existing substances, there is generally a lack of sufficient information publicly available in order to assess and control these substances effectively.
Many countries have similar national legislation and chemical registers. However, the EU authorities’ main concern is that the current systems for ‘existing’ chemicals has not produced sufficient information about the effects of the majority of the traded chemicals on human health and the environment.
As regards ‘new’ substances, the current EU system has also hampered research and innovation. New chemicals manufactured in quantities as low as 10kg were subject to heavy testing requirements, causing the EU chemical industry to lag behind the US and Japan in this regard. In the past 18 years, only 2,700 new substances above 1 ton per year have been placed on the EU market, compared with the around 2,000 chemicals notified in the US every year.
Consequently, the Environment Council decided in 1998 that the set of existing legislation should be reviewed. REACh should replace 40 existing legal acts and create a single system for all chemical substances.
It has always been recognised that the best way of improving safety is by developing international regulations that are followed by all nations. The chemical industry is one of the most highly regulated industrial sectors. This is important in ensuring that the products can be used safely. Good regulation is vital to instil public confidence and maintain good business performance.
With regard to international trade, we have to bear in mind that shipping is perhaps the most international of the world’s great industries and one of the most dangerous.
Today, uniform regulations to manage the risk associated with transportation of dangerous (respectively hazardous) materials – basically chemicals as such and articles which release chemicals – are essentially in place worldwide.
At the United Nations level, all work related to the transport of dangerous goods is coordinated by the ECOnomic and SOcial Council (ECOSOC) Committee of Experts on the Transport of Dangerous Goods (TDG) and on the Globally Harmonized System of Classification and Labelling (GHS). The UN recommendations on the transport of dangerous goods provides procedures on an international basis for shippers and operators that dangerous goods can be safely transported using the appropriate packing, labelling and transport vehicle by air, water and inland.
They continually strive to identify and manage potential hazards, the probability of occurrence of incidents in transportation and the consequences of such incidents. Harmonisation had not been achieved in the workplace or consumer sector. The United Nations Conference on Environment and Development (UNCED), Rio de Janeiro, 1992, provided the international mandate to complete this task.
The GHS has been enveloped at UN level and the plan of implementation of the World Summit on Sustainable Development (WSSD), adopted in Johannesburg in 2002, encourages countries to implement the GHS as soon as possible with a view to having the system fully operational by 2008. The EU has decided to implement GHS at the same time as REACh.
The REACh approach
Of the ‘existing’ substances (approximately 30,000 on the EU market and possibly more than 100,000 worldwide), the possibly dangerous characteristics of the majority have been only incompletely investigated. The manufacturers and importers are required to generate data and to provide a registration dossier. The registration is proposed to take place over eleven years depending on production and usage tonnage:
* 1,000 tons/year – must be registered within 3.5 years
* 100-1,000 tons/year – must be registered within six years
* 1-100 tons/year – must be registered within eleven years
In addition, certain substances, which are identified as being of (very) high concern to human health or the environment, have to be registered early, ie within 3.5 years. The cost to European industry has been estimated by the EU at between €2-6 billion. After eleven years, all chemicals used in the EU market should be properly labelled, packed, transported and used according to GHS requirement – thanks to the REACh regulation.
No data, no market (in the EU)
The most hazardous substances – an estimated 1,500 – could be banned or restricted. Included on that list are some compounds used in electronics, furniture, clothing, toys, cosmetics and other everyday items. Whenever safer substitutes exist for the most dangerous chemicals, they must be used. Companies must submit plans to replace them. Where no alternative exists, the companies should work to find one. This applies to substances that cause cancer, infertility, genetic mutations or birth defects, and to those which are persistent and accumulate in the environment.
REACh also covers downstream users, extending the regulatory scope considerably. It places greater responsibility on industry to manage the risks of chemicals and provide appropriate safety information to professional users and, as far as the most hazardous substances are concerned, also to consumers. Downstream users may be any industrial user of chemicals, whether formulators of preparations (eg paint producers) or users of chemicals such as lubricants (eg fatliquors) in industrial processes such as tanning or producers of manufactured articles such as computers, automotives, textiles or leathergoods.
They are required to consider the safety of their uses of substances, based primarily on information from their suppliers and to apply appropriate risk management measures. Downstream users will need to communicate effectively with their suppliers, to get the information they need in the Safety Data Sheet (SDS) supplied to them.
In particular they will have to check that their use(s) are covered by the SDS. Downstream users have a right to make their use of a substance known to the manufacturer in order to make it an identified use and have it covered in their supplier’s chemical safety assessment. In this case, they have to provide sufficient information to allow the supplier to prepare an exposure scenario for the use. Alternatively, they can conduct their own chemical safety assessment and report this use to the Chemicals Agency.
Restrictions of certain dangerous substances
The use of certain dangerous chemicals is acceptable as long as appropriate risk management measures are implemented. If measures at company level are not sufficient to keep the risks for human health and environment acceptable, REACh foresees limitations or even bans of substances for certain uses, for instance in consumer products.
The most dangerous substances, those of very high concern, will be subject to authorisation. A substance on its own, in a preparation or in an article, for which REACh Annex XVII (replacing Council Directive 76/769/EEC) contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction.
Both the restriction and the authorisation processes can also be applied to substances produced or imported in volumes below 1 ton per year. This would for instance allow risks from particles on a nano-scale to be addressed. The effects of substitution could be broader than one might expect as few things are easily substituted.
It will demand that many firms reformulate products, which may produce inferior products and may trigger need for new registrations.
Outlook
As the EU will probably ban more products under REACh, one can be sure that they will propose they are also banned under international agreements. Some are afraid that this may potentially remove more valuable products from the world market. Many international conglomerates such as automotive, furniture, textile and shoe producers as well as retailers and brands have their own specific lists of unwanted chemicals, so called Restricted Substance List (RSL) and mainly taken from the existing EU regulations.
As chemicals and chemical related articles are traded internationally, chemical safety is a global concern and has inspired a number of international initiatives. The EU is playing a leadership role in all of them. In particular, REACh is likely to become a focus of the UN’s Strategic Approach to International Chemicals Management (SAICM), a relatively new effort designed to create institutions that will coordinate global chemical and waste policies.
However, EU trading partners have suggested REACh would benefit more from harmonisation with existing international regulatory efforts such as accepting test data developed under the Organization for Economic Co-operation and Development (OECD) guidelines and other international or national bodies and using informed substitution.
The high costs of compliance could prove to be a particular burden for some of the smaller companies, both EU and non-EU, and they may not have the resources to comply with REACh, forcing them out of European markets.
REACh is a radical step forward in the EU chemicals management with international impact. Therefore REACh has to be observed closely by all EU trading partners and their representatives including national and international organisations.
Dr Alois G P√ľntener, VESLIC (Association of Swiss Leather Chemists and Technologists), Pulverweg 13, CH 4310, Rheinfelden, Switzerland.
Email: REACH@gmx.ch