Labeling Reproductive Toxicants

When there is generally accepted, well-established evidence that a chemical is known to be a reproductive toxicant it should be labeled with the following statement of hazard or equivalent  

POSSIBLE REPRODUCTIVE HAZARD OVEREXPOSURE MAY CAUSE (FEMALE, MALE) REPRODUCTIVE DISORDER(S)  

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In the case of reproductive toxicity, substances are categorized and labelled according to Appendix VI to the Guideline 93/21/ EEG (10). Within this complex, two different endpoints are considered separately, namely substances which impair fertility and substances which cause developmental toxicity (see Chapter 34). 

The basic idea of the CLH process is the transfer of responsibility for classification and labeling from industrial companies to authorities on a European Community level. In case of active substances in biocidal or plant protection products, all intrinsic properties including physicochemical properties, human health hazards, and environmental hazards are subject to the harmonization. By contrast, in the case of chemicals which are used in other application fields only some specific hazard classes are considered in the CLH procedure. According to Article 36 of the CLP Regulation, these are respiratory sensitization, carcinogenicity, germ cell mutagenicity, and reproductive toxicity. Consequently, these provisions have... 

Proposition 65. Proposition 65, promulgated as part of the California Safe Drinking Water and Toxic Enforcement Act of 1986, requires special product labeling for any product containing any ingredient known to the State to cause cancer or reproductive toxicity. ... 

The competent authority may choose to allow communication of certain hazard information for carcinogens, reproductive toxicity and specific target organ systemic toxicity through repeated exposure on the label and on the SDS, or through the SDS alone (see speeific ehapters for details of relevant cut-offs for these classes). 

NOTE 1 If a Category 1 reproductive toxicant or substance classified in the additional category for effects on or via lactation is present in the mixture as an ingredient at a concentration between 0.1% and 0.3%, every regulatory authority would require information on the SDS for a product. However, a label warning would be optional. Some authorities will choose to label when the ingredient is present in the mixture between 0.1% and 0.3%, whereas others would normally not require a label in this case. 

NOTE 2 If a Category 1 reproductive toxicant or substance classified in the additional category for effects on or via lactation is present in the mixture as an ingredient at a concentration of >0.3%, both an SDS and a label would generally be expected. 

The hazard classification should lead directly to labelling of acute health effects, environmental and physical hazards. The labelling approach that involves a risk assessment should only be applied to chronic health hazards, e.g. carcinogenicity, reproductive toxicity, or target organ systemic toxicity based on repeated exposure. The only chemicals it may be applied to are those in the consumer product setting where consumer exposures are generally limited in quantity and duration ... 

In addition to these regulations, the state of California requires that warning labels inform users of any chemical in the product known to cause cancer or be a developmental and reproductive toxicant. California also has a cosmetics disclosure law that requires the disclosure of all toxic chemicals contained in cosmetics and personal care products. ... 

California has a law, enacted in 1986, Proposition 65, that requires manufacturers to list on the label of their products any significant amounts of compounds in them that might cause cancer or have reproductive toxicity.103 This has prompted companies to reformulate their products to remove such materials. 

The ANSI Guide uses the basic DOT classification scheme with few modifications one is, however, of major importance. An Appendix creates a standard of care for the labeling of serious chronic hazards. Three general classes are established, (1) carcinogen, (2) reproductive toxicants and (3) other serious chronic effects. 

In repeated dose studies in rodents and dogs, liver and kidneys (rat only) were the main target organs. In lifetime rodent studies, only mice showed increased incidences of hver tumors, which were found to be specific to this species [71-73]. They are regarded to be mediated by a non-genotoxic threshold mechanism and of no relevance to man in normal use. Thiamethoxam (13) has no mutagenic potential. Reproductive toxicity studies showed no evidence of developmental impairment or teratogenic potential [13, 37]. Applicator and consumer safety are very favorable for the label recommended uses. 

California Proposition 65 requires a clear and reasonable warning label for all products sold in the state of California containing one or more chemicals known to the state to cause cancer or reproductive toxicity. Labeling requirements are dependent on consumer exposure to the chemical (measured in micrograms (pg/day) not the concentration in the product. To comply with the law, manufacturers must either ensure that consumer exposure to regulated chemicals in their products do not exceed the established safe harbor levels or label their products. 

The California Safe Cosmetics Act of 2005 does not ban such chemicals but requires their labeling on cosmetic products sold after January 1, 2007. The California regulation derives the list of cosmetic chemicals requiring labehng from its Proposition 65 (PROP 65) list of approximately 750 chemicals known to cause cancer or reproductive toxicity [32]. A partial list of the PROP 65 chemicals used in cosmetics is given in Table 11.12. 

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