Complying with North American Regulations

When operating in the US market, one should not ignore the legislation of the country's most economically powerful state, California, where the most important law is California Proposition 65, which applies to all local businesses. The only exceptions are businesses with fewer than 10 employees and government agencies, in which cases compliance with the law is not mandatory.

The purpose of the law was to prevent the release of substances classified as carcinogens and substances causing birth defects into drinking water and to prevent exposure to them. However, the law does not apply only to products that come into direct contact with drinking water or surface water; it covers practically all products sold. Accordingly, products containing listed carcinogens or substances that cause developmental and reproductive disorders must be labelled if exposure exceeds the applicable Safe Harbor Level.

It is important to note that the limit values do not indicate the concentration of a substance in the product, but rather the level of exposure. Therefore, if the hazardous substance in question is not released from the product, there is no reason for concern. It is worth remembering, however, that these limit values are very low, usually in the range of μg/day.

Violations of California Proposition 65 can result in a penalty of $2,500 per day. Accordingly, just six months of exposure could result in a fine of $450,000! However, the law itself does not impose a ban, but rather an obligation to inform. If exposure occurs, it is sufficient to provide labelling in the prescribed format indicating the presence of carcinogenic and/or developmental and reproductive toxicants. In short: California Proposition 65 is not a ban, but a right-to-know regulation.

Is it difficult to identify and comply with the relevant North American legislation? Our team is ready to help overcome such obstacles. Request a quotation for professional assistance.

The North American market has specific legal requirements for manufacturers and importers, which can also affect European suppliers.

For example, in Canada, the PCTS (Prohibition of Certain Toxic Substances 2025) has been significantly tightened, coming into force in June 2026 under the Canadian Environmental Protection Act (CEPA). The regulation restricts the placing on the market of several harmful substances in Canada, including various short-chain PFAS substances, the flame retardant DBDPE, and several other halogen-containing persistent organic pollutants. However, this cannot be considered a complete ban on these substances, as some uses, such as their incidental presence and small-scale laboratory use, are exempted.

Navigating South, in the United States, the most important federal legislation in this area was established by the EPA (Environmental Protection Agency) under TSCA (Toxic Substances Control Act). One of the cornerstones of TSCA is Section 5(a)(2), the Significant New Use Rule (SNUR), which requires to notify the authorities 90 days in advance of a proposed new use of certain substances that is considered significantly new and is potentially hazardous. Another important part of the legislation is Section 6(h), which restricts the

manufacture and import of the following persistent, bioaccumulative, and toxic substances to varying degrees:

• Decabromodiphenyl ether (decaBDE)

• Isopropylated phenyl phosphate (3:1) [PIP (3:1)]

• 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP)

• Hexachlorobutadiene (HCBD)

• Pentachlorothiophenol (PCTP)

Last but not least, it is important to mention Section 8(b) of TSCA, which concerns the US Chemical Substances Inventory. This inventory contains virtually all chemicals that have ever been manufactured, imported, or processed in the country and are subject to the legislation.