Archive: REACH
European Chemicals Policy Prior to REACH
In 1998 a review of European chemicals policy was initiated, which started with the publication of a detailed report on the workings of the above regulations. This study found a large number of problems, with the two most important being related to Existing Chemicals: a lack of available information on the hazards and uses; and an undue burden on the regulator to assess their risks.
In 1999 the European Chemicals Bureau analyzed the data it had received from industry on the properties of existing chemicals produced at over 1000 tonnes per annum (often called high production volume or HPV chemicals). This study found that:
- Only 14% of the EU High Production Volume Chemicals had data publicly available at the level of the base set used for new chemicals marketed at 1 tonne per annum or above;
- 65% had some data but less than base set;
- 21% had no data.
Without this data it was impossible to reliably assess whether most existing chemicals fulfilled the criteria for prioritization for further evaluation in the existing chemicals program. It was also unclear how industry was managing to carry out its responsibilities, such as classification and labeling of chemicals and assessing risks to workers, given the lack of safety information.
Even when there was sufficient data available to place a chemical on the priority lists for assessment by Member State and European Commission experts, difficulties remained as experts tried to complete the risk assessment and management studies. These studies frequently required more data than was available on hazards, and required use information that was either difficult to find or was not available at all.
As a result of these problems, at the end of 2004 only 141 of the over 100,000 existing substances had been placed on priority lists, and only 126 of these 141 substances had at least a first draft risk assessment, with only 70 of these risk assessments being finalized. Of these 70, it was concluded that 57 needed risk reduction measures and 2 needed further information. For only 11 of the 70 substances were further risk reduction measures agreed to be unnecessary (Source: European Chemicals Bureau Newsletter). The fact that so many of the selected substances required further risk reduction measures clearly indicates the need for proper assessment of the risks posed by existing substances.
As a result of the problems found with the current EU system for regulating chemicals, it was decided that a new system should be devised, taking the current system, updating it and making it more comprehensive and effective. Below are some of the policies which REACH replaced.
Classification and Labeling Policies
Council Directive 67/548/EEC , the earliest EU chemicals legislation, created a system for standardizing classification, packaging and labeling of dangerous substances (both industrial chemicals and pesticides). It has since been amended a number of times. Directive 88/379/EEC covers similar areas for ‘preparations’ – a mixture of substances e.g. paint – rather than substances.
Producers are obliged “to carry out an investigation to make themselves aware of the relevant and accessible data which exist concerning the properties of such substances. On the basis of this information, they shall package and provisionally label these substances”. The legislation also specifies the criteria to be used when classifying the dangerous properties of the substance, for example carcinogenicity or reproductive toxicity - an up-to-date text is available here.
In addition to classification by producers, for substances of special concern Member State regulatory authorities work together to produce harmonized classifications. To date around 8000 substances have been classified in this way and added to Annex 1; the results are available for download.
Producers of substances and preparations that meet the criteria for classification as dangerous are also required to create a safety data sheet (SDS) containing information about the substance’s properties; this SDS must be passed on to their customers - for more information, see the European Commission's SDS web pages.
Marketing and Use Restrictions
A directive (76/769/EEC ) agreed in 1976 created a legal structure for harmonizing controls on chemicals across the EU. This directive tends to be used as a reactive tool, after a Member State has raised concerns about a specific chemical. Restrictions agreed under this directive usually only limit substances for specific uses, rather than banning them completely.
Chemicals with certain classifications, for example class 1 and 2 carcinogens, mutagens and reproductive toxins (CMRs), are automatically restricted such that they cannot be sold to the public as substances or in preparations.
The full list of restrictions are listed in Annex 1 of the Directive, which is frequently amended; the latest list is available from the European Commission's Restrictions web site.
Regulation of New Chemicals
All those chemicals which have been introduced to the market at greater than 10 kg/year since September 1981 (and are therefore not on the EINECS list, below) have had to go through the ‘new chemicals’ notification procedure. This process was introduced as an amendment to 67/548 (above). All new substances are listed on the European List of Notified Chemical Substances (ELINCS), see the European Chemicals Bureau for more details.
The new substances notification includes specific pre-market testing and assessment, with testing requirements increasing with tonnage per notifier on the market, in 6 different tonnage bands.
Regulation of Existing Chemicals
Note: The regulatory division between ‘New’ and ‘Existing’ chemicals does not exist for any scientific or risk-based reason. It is a general feature of regulatory systems that it is easier to put new requirements on something that is new (and hasn’t happened yet) than it is to put requirement on something that is already in use.
In order to enable the New Chemicals regulation to function, all chemicals on the European market between January 1, 1971 and September 1981 were listed in the European Inventory of Existing Commercial Chemical Substances (EINECS).
The EINECS database has 100,106 entries, though in reality there are fewer chemicals actually on the market. Recent data from the European Commission’s Joint Research Centre suggests that the numbers of substances in the different tonnage categories are as follows:
- 1-10 tonnes per annum (tpa) — 17,500 substances
- 10-100 tpa — 4,977 substances
- 100-1,000 tpa — 2,641 substances
- >1,000 tpa — 2,704 substances
The Existing Chemical regulation, 793/93, was adopted with the intention of assessing the environment and health risks of Existing Substances by setting priority lists for assessment using the data submitted by industry or other available data. As part of this process, industry has been obliged to submit available data, but there are no specific data requirements, unless a chemical is put on the priority list, when a limited amount of data is required. For more details, see the European Chemicals Bureau's Existing Chemicals web site.
Chemicals on priority lists are then assigned to Member States who produce a risk assessment, and if necessary, risk management proposals which may then feed into the restrictions on marketing and use regulations. The risk assessments produced under the existing chemicals program are long and complex, requiring a significant workload from Member State and European Commission experts, who also have the burden of obtaining the necessary data on chemicals uses, exposures, and hazards. See below for information on progress with the Existing Chemicals regulation.
The detailed technical guidance documents (TGD) which Member State authorities use to guide their risk assessments are freely available on the European Chemicals Bureau web site.
 |
