Regulatory Affairs Expert, Sigma-AldrichⓇ Flavors & Fragrances
With a population of almost 40 million and a Gross State Product (GSP) of $2.75 trillion (€2.43 trillion), the state of California is, by far, the largest market in the USA. Because its economy is larger than most countries (outside of the US, only China, Japan, and Germany have larger economies), regulations on commercial and industrial products in California have a global impact. The 1986 California Proposition 65 (Prop 65) requirements, for example, impact most global consumer products. In fact, most product Safety Data Sheets (SDS) have Prop 65 information, regardless of where the products are marketed.
Like Prop 65, the California Cleaning Product Right to Know Act of 2017 will likely have a global impact on cleaning products and their ingredients, including fragrances.
The California Cleaning Product Right to Know Act of 2017 governs household, institutional, and commercial cleaning products sold in the state of California. Products impacted by the regulation include:
The regulation requires that a broad list of ingredients be declared for every cleaning product sold in California. The ingredients must be listed on the manufacturer’s website by January 1, 2020 and on the product labels by January 1, 2021.
The ingredients required to be listed may include what was previously considered proprietary information. The regulation requires disclosure of any intentionally added ingredient found on any of 22 lists referenced in the regulation, including materials listed on California Prop 65 and materials on the European Union (EU) Carcinogenic, Mutagenic or toxic to Reproduction (CMR) regulation (EC) No 1272/2008.
An industry concern may be the requirement to list many fragrance ingredients. Currently, ingredients added to cleaners in order to add a pleasant odor can be listed simply as “fragrances”. Under the new California law, however, any fragrance ingredient at a concentration of greater than 0.01% (100 ppm) that is also listed in the EU Cosmetics Regulation (EC) No 1223/2009 Annex III must be declared on the manufacturer’s ingredient list. The California Cleaning Product Right to Know Act of 2017 designates these fragrance ingredients as fragrance allergens. In addition to listing these ingredients, the product label must contain the phrase “Contains fragrance allergen(s)”. The (EC) No 1223/2009 Annex III lists over 300 ingredients, and since the threshold is quite low in the California regulation (100 ppm), the requirement will likely impact raw material suppliers and fragrance formulators/blenders as well as the cleaning product manufacturer.
The new regulation does allow for cleaning product manufacturers to protect their proprietary information by declaring some ingredients as “confidential business information”. This declaration of confidential information can include fragrance ingredients if they are not listed on the EU Cosmetics Regulation.
Fragrance ingredient suppliers, regardless of their global location, will likely see increased inquiries on products with respect to the EU regulations listed above. Suppliers should be prepared to offer statements on fragrance allergens and compliance to (EC) No 1223/2009. By supplying their customers with this information, suppliers help keep their products aligned with major regulatory requirements.
A complete text of the California Cleaning Product Right to Know Act of 2017 can be found by visiting California Legislative Information website (leginfo.legislature.ca.gov) and searching for ‘Cleaning Product Right to Know Act’ or for Senate Bill Number 258.
Since the implementation date for the regulation is fast approaching, cleaning product manufacturers should partner with their suppliers to get the information they need to be compliant.
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