68 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS So far there is no indication which criteria will be used to decide the fate of Annex IV substances. Is it the duty of the cosmetic manufacturer, the ingredient manufacturer or some other body to furnish evidence on which judgement can be made? Considerable costs could be incurred in checking a particular substance only to find that some other kind of information is needed. Article 6 relates to labelling and advertising and this involves both Quality and Safety. Point 3 in this article states that special precautions of use must appear legibly on the container or, if this is impossible, on the outer pack and the enclosed leaflet. In Annexes III and IV there are columns headed 'Conditions of use and warnings to be printed on the label'. Not all substances have a requirement of this type, but for those where it is necessary it can be quite wordy. For example, for diamino-benzenes, -toluenes and -phenols it is as follows: 'Can cause an allergic reaction (in persons sensitive to it). Requires a patch test (behind the ear or on the inside of the elbow) at least 24 hours before application. Add particulars of the method of making the patch test.' So the manufacturer must make sure he has room to put this warning on the container or on the package and leaflet and that it is legible, which we must take to mean that the print size is large enough to be read without difficulty. The fourth point of Article 6, although mainly concerned with advertis- ing, is related to quality in that the manufacturer must not attribute characteristics to his products unless there is suitable scientific evidence. In Britain we are already familiar with this requirement in the Trades Descriptions Act of 1968 and most manufacturers have already taken steps to ensure that they can back up their claims. Article 8 is concerned with the supervision needed to ensure that cos- metic products conform to the provisions of the Directive. The responsibility lies with the Member States and so far there is no indication about how much effort will be devoted to this task or how it will vary from country to country. I have already referred to Article 9 when discussing Articles 4 and 5. The first paragraph of the first point requires procedures for the sampling and analysis of products containing substances in Annexes III and IV and the analytical committee are actively working towards this goal. The second paragraph of the first point refers to bacteriological purity and a committee has recently been formed to decide on criteria and methods to ensure that products are acceptable in this respect.

QUALITY AND SAFETY OF COSMETICS IN THE EEC 69 Article 10 provides for the formation of a Committee of Adaptation. This committee will not be set up until the Directive is finally accepted but there is no doubt that it will be very necessary and will probably have a full programme of work. The methods recommended by the analytical com- mittee will have taken into account most of the important factors and they will have been checked against a selection of relevant products on the market but it would be impossible to check every product from every country. This means that there could be some products which are not amenable to testing by the reference method. The onus is on the manufac- turer to check whether his product gives the correct answer when tested according to the reference method. If it does not then he must bring this to the attention of the Committee of Adaptation using the mechanism out- lined in Article 11. Article 12 is of interest in that it allows for the possibility that a product could constitute a danger to human health even though it conforms to the Directive. Member States who find such products can forbid their sale in their territory for one year and they must inform the other Member States and the Commission, detailing the reasons. The Commission must start consultations within 6 weeks and eventually decide if the Directive must be revised. Finally, Article 14 states that when the Directive is finally agreed, all Member States must make the necessary provisions to ensure compliance within 18 months. To summarize, the main points arising from this Directive are as follows. (1) Products must not cause damage to human health. (2) No product can be marketed if it contains any substance listed in Annex II. (3) Products containing substances in Annex 11I must conform to the restrictions and conditions laid down. (4) Products containing substances in Annex IV must also conform to the restrictions and conditions laid down, but at the end of 3 years their use will be reviewed in the light of any new safety data which is available. (5) Products must be correctly labelled and claims must be justifiable. (6) Reference methods will be published for the sampling and analysis of products containing substances in Annexes IlI and IV together with methods for checking bacteriological purity of all cosmetic products. Manufacturers must check that their products can be