Seventh Amendment Directive

TABLE 14.2. Toxicological Testing Requirements under EC Seventh Amendment (Directive 92/32/EC-Notiflcation of New Substances)... 

EEC, Seventh Amendment to EEC Directive 67/548/EEC, "Directive on Classification, Packaging, and Labelling of Dangerous Substances," European Union Commission, Brussels, Belgium (June 5,1992). 

Council Directive 92/32/EEC (392), the Seventh Amendment of the Dangerous Substances Directive (DSD) (391), Council Directive 67/548/EEC, requires pre-marketing notification of new chemical substances. Notification ensures that sufficient information is available on the hazardous properties of new substances for labelling and risk assessment (see Section 14) which will ensure the necessary control measures are in place (67). 

The European Community s Dangerous Substances Directive, DSD (67/548/EEC), was originally adopted in 1967. It regulates the classification, packaging and labelling of dangerous substances. Up until Spring 1992, six amendments have been adopted. A proposed seventh amendment appeared in February 1990, but it was not until April 1992 that it was finally adopted. The major differences between the requirements of the current directive and those which will apply once the seventh amendment is implemented are outlined. 

APHA-AWWA-WPCF, Clesceri, Greenberg and Trussel (Eds.), Standard Methods for the Examination of Water and Wastewater, 17th Edn., 1989. EEC Directive 92/32/EEC (1992/04/30) Seventh amendment of Directive 67/548/EEC. C.3 Microalgae growth inhibition test. 

EEC 1992 Directive 92/32/EEC (1992/04/30) Seventh amendment of Directive 67/548/EEC. C.3 Microalgae growth inhibition test. 

EEC. 1992. Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Off. J. Eur. Communities L 154, 5.6.1992, p. 1. 

Commission Directives 92/95/EEC and 94/14/EC amending the annex of the Seventh Commission Directive 76/372/EEC establishing community methods of analysis for the official control of feeding stuffs. Official Journal of the European Communities L 327 54, 1994. 

Council Directive 2003/15/EC amending for the seventh time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. 

Notification of New Substances Regulations 1993 (NONS 93) implementing part of EC Directive 92/32/EEC, which is the Seventh Amendment of Directive 67/548/ EEC... 

Chemicals (Hazardous Information and Packaging for Supply - CHIP) Regulations 2002, which implements Directive 67/548/EEC and its seventh amendment 92/32/ EEC, the Dangerous Preparations Directive (99/45/EC) and its amendments, and the Safety Data Sheet Directive (91/155/EEC)... 

New chemical notification schemes vary considerably between countries, but many base the studies for full notification on the OECD minimum pre-maiketing set of data (MPD) the EC, certain EFTA countries, Australia and the imminent Canadian scheme (See Table 34.1). Only a few studies additional to the EC Base Set are needed fw full notification in Austria and Switzerland. Chemical control legislation in Scandinavia is in the iwocess of being changed, in order to achieve the intended harmonization by 1 January 1995 of chemical control legislation between the EC and 6 of the EFTA countries under the new European Economic Area (EEA). The EC notification scheme will have been updated by then, under the Seventh Amendment Council Directive 92/32/EEC [12], which was brought into force by 31 October 1993. Thus the current Finnish new chemicals notification scheme will be modified to confoim exactly to that of Council Directive 92 2/EEC as from 31 October 1993, and the proposed notification schemes for Norway and Sweden will also have to be in harmony with the EC. 

The MPD is tecommended by the OECD for adequate hazard assessment of new chemical substances. Full notification for supply in the EC at 1 tonne a (or S tonnes cumulative) under the Seventh Amendment Council Directive 92/32/EEC [12], Note that a screening test for toxicity to reproduction will ako be required as part of the Base Set when a snitaUe method has been developed. 

Council Directive 79/831/EEC [22] (which is the Sixth Amendment of Council Directive 67/348/EEC) requires pre-marketing notification of new substances, and classification, packaging and labelling according to the degree of hazard. Thus sufficient information on new substances is available to enable the hazard to be assessed and any necessary control measures to be taken. The EC notification scheme has been updated by Council Directive 92/32/EEC [12] (ie, the Seventh Amendment of Council Directive 67/548/EEC), which is to be brought into force by 31 October 1993, and hence the revised scheme is discussed. 

A rapporteur Competent Authority will be selected to conduct the risk assessment on each priority chemical. A Commission Directive has to be adopted by 4 June 1994 to set out the principles for risk assessment The CEC will publish detailed guidelines on how to conduct the assessment, which can be updated and revised as necessary. This risk assessment scheme will correspond closely with that fm notified new chemical substances required under the Seventh Amendment (Council Directive 92/32/EEC [12]). 

The Austrian Chemicals Law of 1987, which does not apply to H oducts regulated by other legislation, requires notification of new chemical substances, and regulations implementing this were issued in 1989. The notification system is similar to the former Sixth Amendment EC scheme of Council Directive 79/831/EEC. [22]. In due course the Austrian notification scheme will in principle become harmonized with the updated Seventh Amendment EC scheme of Council Directive 92/32/EEC [12], because Austria is one of the 6 EFTA countries participating in the agreement with the EC to form the EEA. 

The Chemicals Act requires new chemical substances to be notified by the Finnish manufacturer or importer 45 days before they are supplied in Finland. Existing non-notifiable substances are those listed in EINECS or supplied in Finland before 1 September 1990. The Finnish notification scheme closely follows the revised EC system under the Seventh Amendment Council Directive 92/32/EEC [12], but differs in certain details because it was based on the proposed Seventh Amendment not the final version. However, as from 31 October 1993 when Council Directive 92/32/EEC comes into force in the EC, the Finnish notification scheme will be amended to be fully harmonised. 

A notification scheme for new chemical substances is scheduled to be in force on 1 January 1994. This Swedish scheme will be fully harmonized with the Seventh Amendment EC scheme of Council Directive 92/32/EEC [12], and use EINECS to define existing substances. 

As we mentioned in the previous chapter, its approach used a codification system (Risk Phrases) that was based on toxicological evidence of harm arising from exposure to substances. Criteria for codification were set out in Annex VI to the Dangerous Substances Directive (67/548/EEC) as amended by its Seventh Amendment (92/32/EEC). Annex I to the Dangerous Substances Directive included risk phrases (R-phrases) for all substances with an agreed hazard classification in the EU. This information was reproduced in the UK in the Approved Classification and Labelling Guide (Third Ed.) whilst specific substances and their R-phrases were listed in the Approved Supply List. If any substance supplied to a workplace within the European Community was not listed in Annex I to the Directive, the supplier was required to consider whether a hazard classification was appropriate and if so, based on the classification criteria, apply the appropriate R-phrases as well as other information. 

For more than 30 years work has been going on involving food contact plastics and the effect that migrants from plastics products have on food. The first European Directive (78/142/EEC), which was on the vinyl chloride monomer content of food contact PVC, was published in the late 1970s and this was followed ultimately by the more comprehensive Plastics Directive (90/128/EEC) in 1990. Since 1990, there has been a gradual harmonisation of European testing requirements through amendments to 90/128/EEC. The seventh amendment (2002/17/EC) has recently been... 

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