Chemical substances are an extremely important international commodity. This branch in particular has long been strongly specialized, and many of the products have depended on a multinational market. The EC began attempts to harmonize the area as early as 1967, i.e. before the term "environment" came into political vogue. Since then harmonization has been intensive and, at least with respect to environmental law, the chemicals area is the most closely harmonized of all areas. Thus while at most 50% of the Danish regulations covering other areas derive from EC law, the figure for the chemicals area is 75-80%. Moreover, all th e most central sets of regulations have been harmonized within the EC.
The OECD has played a major role in the chemicals area, partly because chemicals are marketed throughout the whole of the Western world, and partly because the OECD has been able to contribute to strategy development in relation to chemicals. Certain EC rules even derive directly from OECD Guidelines, e.g. the Directives on good laboratory practice.
The idea of controlling new chemical substances (see Section 9.2) accords well with the line of reasoning common to the Western world. It was first introduced in the USA, but was rapidly taken up in the EC.
However, before the EC had got that far, some 100,000 substances had been placed on the market; in most cases, moreover, systematic investigations of their toxicity are lacking. An attempt to redress this problem is being made by initiating such investigations for the most important substances (see Section 9.3).
Denmark plays a relatively modest role in the European chemicals market, but Danish farmers consume considerable amounts of chemicals, and chemicals comprise an increasing part of Danish industrial production. Some 20,000 chemical substances are estimated to be on the market in Denmark; they are incorporated in approx. 55,000 products, all of which are registered in the Danish Product Register. This is a government inventory that is available for the use of relevant authorities (the Danish Working Environment Service and the Danish EPA) and physicians faced with cases of poisoning.
Chemical substances have not been taken for granted as being an environmental province. Thus in the EC, division is made between General Directorate XI (Environment), which has jurisdiction over pure substances, General Directorate III (EC Internal Market), which has jurisdiction over products, and General Directorate VI (Agriculture), which has jurisdiction over plant protection products.
In Denmark there has been some doubt as to whether chemicals should be the province of the Danish Working Environment Service or the Danish EPA. The task has been divided such that the Danish Working Environment Service regulates chemicals in the working environment, while the Danish EPA has jurisdiction over other matters, including the question of labelling. In recent years the "cradle-to-grave" philosophy has made it clear that the legislation governing chemical substances is an important part of environmental legislation. The Environmental Protection Act aims primarily at the environmental problems associated with the production processes per se, while the Chemical Substances and Products Act makes it possible to intervene in subsequent phases such as consumption and waste.
It should be noted that administration of the Chemical Substances and Products Act is centralized in the Danish EPA, virtually no authority being delegated to the local environmental authorities. The reason for this is that the area demands considerable specialization. The administrative workload for the Danish EPA corresponds to approx. 60 man-years.
In the following I will first deal with the rules that are common to all chemical substances, whether they be used in agriculture or industry: Firstly, rules on classification, labelling and packaging (9.1); secondly, rules on notifying new substances (9.2); and thirdly, rules on export out of the EC and investigation of existing substances. Thereafter I divide the topic according to usage. First I deal with pesticides (9.4), the most important group of which is agricultural chemicals - plant protection products. Finally I deal with other hazardous substances in Section 9.5, which I have entitled "Industrial chemicals" but which in fact covers a very broad group.
9.1. Handling of dangerous substances
When handling dangerous substances, one has to be careful and responsible. This requirement has long been incorporated in the legislation of many countries.
The EC has been systemizing it since 1967 by building up a uniform system for the classification, packaging and labelling of dangerous substances.
Classification comprises grading the substances in danger classes and assigning a risk declaration (R-phrases) and safety instructions (S-phrases). It is the responsibility of the manufacturer or importer to ensure that substances are correctly classified.
Examples of danger classes are "Very toxic", "Toxic", "Harmful", "Carcinogenic", "Explosive" and "Dangerous for the environment". Each class has its own symbol. "Very toxic" and "Toxic" are symbolized by a skull and crossbones, while "Harmful" is symbolized by a St Andrews cross. Chemical substances for ordinary household use must not be more dangerous than "Harmful".
Classification is based on the substances toxicity and physicochemical properties. A substance is classified as "Very toxic" if 25 mg of the substance is sufficient to kill at least 50% of a group of rats weighing 1 kg in all. If 25-200 mg of the substance is required, it is classified as "Toxic", and if 200-2,000 mg is required, it is classified as "Harmful".
There are approx. 60 R-phrases and a corresponding number of S-phrases. An R-phrase could for example be "Very toxic if swallowed" while an S-phrase could be "If swallowed, seek medical advice immediately and show this container or label".
Labelling requirements are that the substance shall be supplied with a specified label that has to include danger symbols, R-phrases and S-phrases.
Requirements on safe packaging are also included in the EC regulations.
The EC regulations have been implemented unamended in Danish law. A list of dangerous substances has been drawn up comprising 1,400 substances. It is a list of those dangerous substances that have so far been classified by the EC. This notwithstanding, manufacturers or importers that market other substances are responsible for ensuring that an evaluation is undertaken of whether the substances should undergo classification as dangerous substances.
With respect to packaging, the Danish requirements are that all dangerous substances sold to consumers must be sold in child-proof containers.
Danger symbols and terminology for hazardous chemical substances.(common to all EC
Member States)
Further to this, toxic substances, i.e. substances classified as "Toxic" or "Very toxic", have to be stored in a locked room or cupboard.
The Danish regulations also stipulate who may sell and who may purchase toxic substances. Thus, the general public are not allowed to purchase such substances except for photographic solutions and artists paint.
If one is not encompassed by the list of trade and industry groups freely permitted to purchase toxic substances, the only way to legally purchase them is to fill out and sign a requisition that has then to be endorsed by the police.
In addition to having to comply with the specific regulations, one has also to behave responsibly when dealing with dangerous substances. Irresponsible handling and use of dangerous substances that endangers the health or life of man or animals or causes significant damage to the environment is a punishable offence.
Denmark has twice invoked the safety clause (Article 31) of Directive 67/548 in respect of classification - in 1987 and 1988, in both cases pursuant to a parliamentary decision. In 1987 it was invoked concerning the classification and labelling of 23 substances that Denmark considered to be carcinogenic. The case resulted in the EC as a whole accepting to label 19 of the substances in the way that Denmark wanted. In 1988 it was invoked concerning the classification and labelling of 13 organic solvents that Denmark considered as capable of causing brain damage. The case resulted in the EC accepting to label 3 of these substances in the way that Denmark wanted. In the case of the remaining substances, Denmark had to give up labelling them as carcinogenic/liable to cause brain damage. However, with one of the substances, mineral turpentine, the EC has not yet reached a decision and Denmark maintains its national requirements.
Progress with respect to the regulation of dangerous substances should
be judged from the number and extent of accidents attributable to their incorrect handling
and use. No systematically collected data is available, however.