The EU biocide regulation and EU detergent regulation each apply to specific finished products, on top of REACH and CLP, and California's Prop 65 adds a warning rule for products sold there. If you import finished cleaners, disinfectants or preserved goods from India, these rules matter more than the raw-material rules.
In each case the person placing the product on the market carries the responsibility. Your Indian supplier can supply data and formulations, but cannot discharge your legal duty.
What does the EU biocide regulation require?
The Biocidal Products Regulation (EU) 528/2012 covers products that kill or control organisms, such as disinfectants, wood preservatives, in-can preservatives and insecticidal products. A biocidal product generally needs authorisation before it is made available in the EU, and its active substances must be approved for the relevant product type.
Article 95 adds a supply-chain rule. The supplier of the active substance, or of the product, must be on the Article 95 list for that product type, or the product cannot lawfully be placed on the market. Ask your supplier whether it, or the substance's producer, is listed. Goods treated with biocides, such as treated textiles or paints, also face labelling duties.
What does the EU detergent regulation require?
Detergents have been governed by Regulation (EC) 648/2004, which sets biodegradability requirements for surfactants, ingredient labelling and information duties. A separate regulation limits phosphates in consumer laundry and dishwasher detergents. Hazardous detergent mixtures must also be notified to poison centres under CLP before they are placed on the market.
The Commission proposed a replacement detergents regulation in 2023. Check the current legal status on EUR-Lex before you fix label artwork, as the rules and transition dates are the part that changes. For a private-label cleaner, read our guide to private-label cleaning products from India alongside this article.
What is California Prop 65?
Prop 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, requires a clear and reasonable warning before knowingly exposing people in California to listed chemicals. The state's Office of Environmental Health Hazard Assessment maintains the list of chemicals known to cause cancer or reproductive harm, and updates it regularly.
Businesses with ten or more employees are covered, and private parties can bring enforcement actions. An importer or distributor can be pursued even if it did not make the product. Check the OEHHA list against your formulation, and decide whether the product needs a warning or a reformulation.
How to check a finished product before import
- Ask for the full formulation, under an NDA if needed, so a regulatory author can check every ingredient.
- Confirm the REACH and CLP status of each component using the guides on EU REACH and CLP labelling.
- For US sales, check TSCA listing and the Prop 65 list.
- Make sure the label follows the rules for your market, starting from GHS label basics.
How we help
We check whether a supplier can document its ingredients, audit the plant, and have samples tested. A regulatory consultant should then confirm your market's rules. To start, book a free sourcing review.