Lafon D
Département études et assistance médicale, INRS, centre de Paris, 30, rue Olivier-Noyer, 75014 Paris, France.
Gynecol Obstet Fertil. 2006 Oct;34(10):950-4. doi: 10.1016/j.gyobfe.2006.06.021. Epub 2006 Sep 25.
European regulations (transcribed into French law) aimed at protecting employees from chemicals toxic to reproduction enable classification and labelling of such substances, if they are liable to cause an alteration of male or female reproductive functions or capacity, or to induce non-hereditary harmful effects on their offspring. Three categories can be used to classify these substances in two areas, namely their impairment of fertility and their effects on development. This classification is rarely based on epidemiological study results, but most often on those of experimental toxicological studies conducted by substance manufacturers. These reproduction toxicological studies are only compulsory above a certain tonnage placed on the market. The high level of this tonnage means that these tests are effectively only conducted on rare occasions. It is reckoned that there is no reproduction experimental data for over 95% of substances newly placed on the market. These products therefore appear to be reproduction non-toxic only because they have not been tested. This is a major fault in the current labelling system, which does not allow non-toxic products to be differentiated from non-tested products. The future EU regulatory framework for Registration, Evaluation and Authorisation of CHemicals (REACH) will only slightly enhance information in this area. It can be estimated that over 80% of chemical products will not be exhaustively tested for reproduction and nearly 75% will not be tested to any degree.
旨在保护员工免受对生殖有毒化学品危害的欧洲法规(已转化为法国法律),使得此类物质能够进行分类和标签标注,前提是它们可能导致男性或女性生殖功能或能力的改变,或对其后代产生非遗传性有害影响。可使用三类在两个方面对此类物质进行分类,即对生育能力的损害及其对发育的影响。这种分类很少基于流行病学研究结果,而大多基于物质制造商进行的实验毒理学研究结果。这些生殖毒理学研究仅在投放市场的一定吨位以上才是强制性的。这个吨位水平很高,这意味着这些测试实际上只在极少数情况下进行。据估计,超过95%新投放市场的物质没有生殖实验数据。因此,这些产品似乎仅因为未经过测试而显得无生殖毒性。这是当前标签系统的一个重大缺陷,它无法区分无毒产品和未测试产品。未来欧盟的化学品注册、评估、授权和限制法规(REACH)只会在这方面略微增加信息。据估计,超过80%的化学产品不会进行全面的生殖测试,近75%的产品根本不会接受任何程度的测试。