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.