QUALITY AND SAFETY OF COSMETICS IN THE EEC 67 I propose to highlight those parts which relate to Quality and Safety. Article 2 states that 'Cosmetic products put on the market within the Community must not be capable of causing damage to human health when they are applied as directed'. The bland kind of statement with its complete lack of definition leaves many unanswered questions. For example: What are the criteria for damage to human health?... How should this be tested?... Should animals or human subjects be used?... How many should be tested?... What protocol should be used?... How should results be interpreted ?... etc. etc. It will undoubtedly be the responsibility of the manufacturer to provide evidence that his product cannot cause damage to human health but no guidance or recommendations about the way this should be done are available. So for the time being the manufacturer continues to meet his own criteria regarding the safety of his product when used as directed. Article 3 states that 'Member States shall take all the necessary measures to ensure that only cosmetic products which conform to the provisions of this Directive and its Annexes can be put on the market', and Article 4 says that 'Member States shall prohibit the marketing of cosmetic products containing (a) the Substances in Annex II, (b) and (c) the substances in Annex III part 1 and 2 outside the limits and conditions fixed'. There is an EEC committee of analysts whose task is to recommend reference methods for checking whether products comply with the restrictions laid down in Annex IlI, but there is little indication that ways of detecting the possible presence of the long list of substances in Annex II will ever be considered. This must imply that the manufacturer is put on trust not to include any of these substances. It does not require much imagination to envisage the in- superable problems which could be created by an over-zealous Member State. Then we come to the Provisional List (Annex IV). This is covered by Article 5 which states that 'For a period of 3 years... Member States shall accept marketing of cosmetic products containing the substances in Annex IV parts 1 and 2'. The same analytical committee is considering reference methods for products containing substances in this Annex. But what happens at the end of three years ? This is covered in Article 9 part 3: 'On the basis of the results of scientific and technical research the substance provisionally accepted shall at the end of three years be --Finally included in Annex II or Ill --or kept for a further period of 3 years in Annex IV --or removed from any Annex to this Directive.'

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.