European Union Directives

The directive defines a 'cosmetic product' as:

'any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition'.

Most of the provisions of this directive relate either to human health, consumer protection or packaging/labelling. Of interest to animal groups in relation to the latter is the end of Article 6 (3):

'Furthermore, any reference to testing on animals must state clearly whether the tests carried out involved the finished product and/or its ingredients'.

Article 4.1. deals with the question of a ban on animal testing; it provides:

'Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products containing:' sub para (i) of this Article states:- 'ingredients or combinations of ingredients tested on animals after 1 June 2000 (amended from 1 January 1998) in order to meet the requirements of this Directive.

However, the second subparagraph goes on to state:

'If there has been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection for the consumer, taking into account OECD toxicity test guidelines, the Commission shall, by 1 January 2000 (amended: was 1 January 1997), submit draft measures to postpone the date of implementation of this provision etc.'

In addition to categories of cosmetic product (Annex I), the directive includes lists of substances banned from cosmetic products (Annex II), lists of substances which may only be used under specified circumstances (Annex III) and lists of permitted colouring agents, preservatives and UV filters (subject to conditions laid down).

Council Directive 86/609/EEC of 24 November 1986 on the Approximation of Laws, Regulations and Administrative Provisions of the Member States Regarding the Protection of Animals used for Experimental and other Scientific Purposes

This is the main legislation on the protection of experimental animals at Community level. It contains provisions similar to those in the European convention. Key provisions include:

• Use of animals in experimentation limited to specified categories;
• Conditions on the general care and accommodation of the animals including housing, environment, food, water and care: restrictions on physiological and ethological needs limited;
• Environmental conditions checked daily;
• Health and welfare of animals to be observed by competent person;
• Defects or suffering found to be eliminated/rectified immediately;
• Experiments to be performed solely by competent authorised person, or under direct responsibility of such a person;
• Experiments using animals not to be performed if satisfactory alternative available;
• Choice of species to be considered carefully;
• Minimise number of animals and minimum degree of suffering;
• Experiments on animals taken from the wild not to be carried out unless experiments on other animals would not suffice for the aims of the experiment;
• Experiments to be designed to avoid stress and unnecessary pain;
• All experiments to be carried out under general or local anaesthetic (with specified exceptions);
• If anaesthesia is not possible, analgesics or other methods of pain limitation to be used;
• An anaesthetised animal suffering once anaesthesia is wearing off to be treated with analgesia (except where incompatible with aims of experiment), or killed humanely;
• At the end of experiment, animal to be killed humanely if it is likely to remain in lasting pain or distress;
• If an animal is to remain alive at the end of an experiment, it should receive (veterinary) care as appropriate to its state of health;
• Animals not to be used more than once in painful experiments;
• Member States to establish a system of prior notification of experiments;
• Where an animal is likely to suffer prolonged pain, the experiment must be specifically declared and justified, or subject to an authorisation system by the competent authority;
• Provisions concerning the supply of statistical information and the keeping and retention of records;
• Persons who carry out experiments or care for laboratory animals shall have appropriate education and training;
• Breeding and supplying institutes to be approved and registered with the competent authority (having proper conditions and care for the animals, trained staff, record-keeping etc.);
• Supplying institutes only to buy animals from registered breeders;
• No stray or feral animals to be used in experiments;
• Each dog, cat and non-human primate used in any breeding, supplying or user establishment to be individually identified and registered (with full records kept of movement);
• Particulars of each dog, cat and non-human primate to be recorded, including origin;
• User establishments to be registered with the competent authority (with conditions governing installation, equipment, design, construction, methods etc.);
• Sufficient number of trained staff to be employed in user establishments;
• Nominated person to be responsible for the welfare of the animals;
• Arrangements to be made for veterinary advice and treatment, and a veterinary advisor nominated;
• Provisions governing record keeping and inspection by the member state and Commission;
• Mutual recognition - member states to recognise experimentation data from other member states to avoid unnecessary duplication of experiments; and
• Member states to encourage research into the development and validation of alternatives to animal experiments'

Annexes include:

• List of experimental animals covered by the provisions of Article 21 (purpose bred animals);
• Guidelines for accommodation and care of animals (including minimum cage sizes).

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