What is REACH for?

The European chemical industry is one of the most important production sectors in the European Union, and still the largest chemical industry in the world. It has a share of the world market amounting to approximately 31%. The size of the sector is apparent from its employment numbers. A total of 1.7 million people work directly in the chemical industry, with some 3 million jobs depending on the sector.

Chemical substances make up an unmistakable part of our world and play an important part in the economy. Unfortunately we must also observe that a large number of these substances comprise problems as regards health and the environment. Numerous scientific publications demonstrate that the incidence of certain cancers, allergies and problems with the hormonal system continues to increase, in particular among children . All these illnesses are caused by different factors and can therefore certainly not be solely attributed to exposure to hazardous substances, but increasingly clear links are being made between the development of these clinical pictures and exposure to chemical products.

Until the Reach Regulation, the European legislation made a distinction between ‘existing’ and ‘new’ substances. The existing substances were all chemicals that appeared on the market before 18 September 1981. All existing substances are mentioned on the European Inventory of Existing Commercial Chemical Substances (EINECS) list. This is a group of approximately 100,000 substances. No one knows how many of them are still produced and brought on the market today. The ‘new’ chemical substances have been put on the market after 18 September 1981 and are on the European List of Notified Chemical Substances (ELINCS) list. This list consists of some 4,300 substances.

Most substances are put on the market as mixtures. According to the European Commission, some one million chemical preparations are put on the European market.

The European Commission estimates that approximately 10,000 substances are brought on the market in volumes of over 10 tons a year. Of these, some 2,500 are HPVCs (High Production Volume Chemicals). These substances are brought on the market in quantities of more than 1,000 tons a year. Barely or no information exists on about 85% of the 2,500 HPVCs. The situation could be even worse for substances produced in smaller quantities.

In 1981 it became compulsory for chemical substances to be tested before being brought on the market. This, however, only applied to the ‘new’ substances. The obligation consisted of providing a basic set of information before they were brought on the market and as soon as they were produced in quantities of over 10 kg a year (notification according to Directive 67/548/EEC). The market share of these ELINCS substances is only 1%. There has been no obligation of the systematic testing of the ‘existing’ substances so far. There is, however, a Regulation (793/93/EC) prescribing that information must be collected on existing chemical substances produced in large quantities. Responsibility for the identification of these existing substances and the collection of the information lies with the authorities. As a result there is a general lack of knowledge of the properties and uses of these substances. These Regulations were highly favourable to the industry. The government indeed had to demonstrate the harmfulness of a product. A company did not have to prove its product was harmless. Consequently, experts were overwhelmed by expensive assessments that required a lot of time and that were continuously contested by the industry. In the meantime the industry itself just continued polluting the environment and harming health.

In 1993 the national authorities selected 141 substances from the 2,500 substances produced in high volumes. A comprehensive risk analysis followed. Although the process was already started in 1993, at the end of 1999 work had only been completed on three of the 141 substances.

Bron: 'Public Availability of data on EU high
production volume chemicals', European
Chemicals Bureau, Joint Research Centre,
European Commission.

With that policy there was no success in effectively and efficiently eliminating the gaps in our knowledge of the chemical substances. Furthermore, according to that legislation only manufacturers and importers were obliged to provide information about the chemical substances they were marketing. This obligation did not exist for users purchasing the products. It is therefore very difficult to obtain information about the use of the substances and the resulting exposure. Mainly for these reasons it was decided to review the legislation. In 2003 this led to the proposal of the REACH Regulation. REACH fits in with the overall objective of sustainable development. The Regulation entails new rights and obligations. Certain substances could disappear from the market or be subjected to certain conditions. REACH could also represent new opportunities for your company.

REACH also wants to ensure that information is made available on chemicals from before 1981. Since 1 June 2007 the distinction between 'new’ and ‘existing’ substances‘ has also been removed, being replaced by information requirements depending on the tonnage and danger of the substance. Besides the ‘new’ substances coming on the market, REACH also wants to generate information on the estimated 30,000 ‘existing’ substances. This is an estimate of the total number of substances marketed in volumes of over 1 ton a year. Under REACH a transitional period applies for these 30,000 substances. They will have to be registered by gradual integration, within three, six or eleven years depending on the tonnage category and danger.
Hence ’existing’ substances, under REACH, become ‘phase-in substances’. The substances called ‘new’ under former legislation ,will - under REACH - be called ‘notified substances’ because these substances have according to Directive 67/548/EEC already been notified or registered. For these substances there applies a registration obligation from 1 June 2008.

Substances not on the EINECS- or ELINCS list are - under REACH - called ‘non-phase-in substances’.

A number of reasons are mentioned for this new policy:

• Health and the environment: From an environment and health perspective it is important to develop a coherent policy for chemical substances. The European Union estimates that by virtue of REACH health will improve by 1% because it is expected that 10% of illnesses related to hazardous substances can be prevented. According to the final report of the School of Health and Related Research  over a period of 10 years REACH can prevent 40,000 cases of respiratory diseases and 50,000 cases of skin diseases among employees.
• Savings: Certain chemical substances such as asbestos can lead to diseases. This results in economic losses in the form of damage to health, social losses and environmental problems. Estimates of the savings vary greatly. Proponents mention savings of many hundreds of billions of euros. Opponents, on the other hand, maintain that the system will not achieve its anticipated returns. The cost of REACH is estimated at €1.00/person/year over the implementation period of 11 years.
• Transparency: REACH simplifies legislation on chemical substances. What is now an incomprehensible jumble of various national and European laws will be transformed into one coherent and clear law. Because each potential registrant must indicate with which substances he works, in which quantities and in which applications the substances are used by him and its clients, transparency will obviously increase.
• Information: Besides the label, the safety data sheet (SDS) is the most important indicator of possible dangers of a substance. In practice it is particularly the (eco) toxicological component that is poorly documented (‘no information’ or ‘no known information’). With the introduction of REACH this will become a thing of the past, and requirements are made on the quality of the content of the safety information. Furthermore, this more complete information about the safety of chemical substances will be available to consumers who will be able to consult this information more easily.
• Innovation: New studies show that in the long term REACH will stimulate the development of new chemicals and create markets for safer products. Besides being found to be complex, the former system of rules also worked as a brake on innovation. This is particularly because of the distinction between ‘new’ and ‘existing’ substances.
• Safety: REACH obliges companies - who produce, import and/or use chemical substances - to collect information, assess risks and take measures to manage any possible risks. The former system, where it was mainly the government who had to assess the danger of substances, was here, as it happens, insufficient.