Spielwarenmesse: Proposition 65: Requirements concerning harm­ful substances in children’s products

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Safety

Proposition 65: Requirements concerning harm­ful substances in children’s products

from Stefan Schmitz

The Safe Drinking Water and Toxic Enforcement Act of 1986 – also known as California Proposition 65 or CP 65 in short – is a piece of legislation in the US state of California concerning carcinogens and reproductive toxicants. The Proposition 65 requirements pose significant problems for smaller companies in particular. It is especially important for toy manufacturers not to have Proposition 65 warnings on their products.

The initial intention behind Proposition 65 was to protect sources of drinking water from carcinogens and reproductive toxicants. In this context, it was also decided that consumer exposure to such substances through toys or other household products, for example, should be eliminated or, at least, reduced. To this end, it became necessary to put warning labels on consumer products.

Not least in the area of toys, it is extremely important for many companies that their products can be marketed without such warning labels.

Proposition 65 – the fundamentals

Products that expose consumers to chemicals which the state of California has identified as carcinogens and/or reproductive toxicants must carry a warning label. The list of these chemicals now includes approximately 900 entries and is regularly updated by the Office of Environmental Health Hazard Assessment (OEHHA).

However, only 400 of these entries, at most, are relevant to consumer products, and toys in particular, as conventional pharmaceuticals and most of the listed biocides are not found in such products, for example. Chemicals of general concern under Proposition 65 are:

  • Phthalates such as DEHP and DINP
  • Lead
  • Cadmium
  • Bisphenol A
  • Some polycyclic aromatics such as benzo[a]anthracene
  • Polybrominated biphenyls
  • Ethylbenzene
  • (Azo)dyes (e.g. C.I. Direct Blue 218)

A warning label is required if listed chemicals are contained in the product or consumers might be exposed to such substances. This might mean exposure via dermal (skin), oral (swallowing) or inhalation routes.

Practical example

Polybrominated biphenyls may be used as flame retardants in the electronic components of a remote-controlled toy car. As these components are found on the inside of the vehicle, oral and dermal exposure can normally be disregarded. These substances are not released, either, so inhalation exposure can also be disregarded. Therefore, no warning label is needed. However, a warning label is required if ethylbenzene is contained in the rubber tyres, as a child may well touch the tyres or even put them in their mouth.

Example of a warning label under Proposition 65

The potential buyer must be informed in a “clear and reasonable way” before any possible exposure (see Fig. 1). The warning label begins with a yellow warning triangle with an exclamation mark, followed by “WARNING:”. There are then various warning texts depending on whether the substances in question are carcinogens, reproductive toxicants or both. However, at least one substance (per risk) must be mentioned in any case. The warning finishes with a link to the Proposition 65 website (www.P65Warnings.ca.gov).

Limits and case law

The Proposition 65 substance list sets two limits: a No Significant Risk Level (NSRL) for carcinogens and a Maximum Allowable Dose Level (MADL) for reproductive toxicants. In general, these limits fall under the term safe harbor level.

Unlike in EU regulations, these limits are based on the level of exposure to a substance, rather than the amount contained in the product/material. This means that there is no requirement for a warning about DEHP in a ball made of PVC provided the daily oral intake is kept below 410 mg/kg-day.

However, these official limits are not all that is used to assess a product or toy. So-called “settlements” can also provide information about limits. Settlements are simply court proceedings in which companies have been charged for not following or incorrectly following Proposition 65, such as by not complying with limits and failing to provide a warning label as a consequence. Product-specific limits have usually been determined in such court proceedings. These are not based on exposure, but on the content of the chemical in question. In relation to the PVC ball mentioned, an appropriate limit would be 1000 ppm (= 0.1%).

DEHP is a good example, as the same limit has been given in all settlements. With lead, however, there have been a multitude of settlements with different limits according to the product and product category and products have even been banned from the Californian market in some cases.

Either way, convictions result in corresponding penalties, which include a fine to be paid to the state of California, the payment of all legal costs and a reward for the citizen who noticed the particular “infringement”. Ultimately, the defendant must also bear the costs of the further implementation of the judgment, such as the relabelling or reformulation of the product.

As the seller of a product may not necessarily be its manufacturer, responsibility is generally passed on contractually to the respective supplier. This means that foreign companies may be (indirectly) responsible for compliance with Proposition 65 via such relationships.

Practical recommendations with regard to Proposition 65

The Proposition 65 requirements pose significant problems for smaller companies in particular. Although Proposition 65 states very clearly that a product which contains a listed substance to which consumers may be exposed must carry a warning label, even large companies cannot have all of their products analysed for all Proposition 65 substances.

It is especially important for toy manufacturers not to have Proposition 65 warnings on their products. There are several aspects which manufacturers should be mindful of when making their products compliant with Proposition 65:

  • Examine your products
    What materials do they contain? Which substances might be found in these materials and which not? This will narrow down the list of chemicals to a much more manageable number.

  • Do you have information on the materials?
    Suppliers frequently provide information on materials and may even confirm Proposition 65 compliance.

  • Think outside of the box!
    Some Proposition 65 listed chemicals are already covered by regulations in other jurisdictions, such as the EU. Lead and DEHP are already on the REACH/SVHC list and must be declared if the content is greater than 0.1%. California has adopted the European RoHS Directive for electronics almost in its entirety, which means that RoHS-compliant products – with respect to the substances named there – are also compliant with Cal-RoHS and Proposition 65 in California. In the case of toys in particular, other US (federal) legislation, such as the Consumer Product Safety Improvement Act (CPSIA), also sets out limits that are recognised by Proposition 65.

  • Manufacturers that make it this far will have surely identified some gaps that could be filled through laboratory analysis.

  • Once all of the data has been collected, all that remains is to assess the level of exposure. How might exposure actually result? Which limits in respect of the exposure (from the safe harbor level) and in respect of the content (from the settlements perspective) or other areas of law apply? The data collected makes it possible to ultimately work out whether or not a warning label is needed.

If a warning label is indeed required, this approach also helps directly identify which substance is responsible for the warning label requirement and where an alternative might or must be sought.

Conclusion

At first glance, Proposition 65 seems an opaque directive with a number of vagaries and difficult requirements. But it, too, can be managed by taking a structured approach.

 

Author of this article:

Stefan Schmitz, DEKRA

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