An endocrine disruptor is a substance (chemical, natural, drug,...) that can interfere with the body's endocrine system. These substances interfere with natural hormones that regulate functions such as growth and development, metabolism and reproduction by three main mechanisms.
Endocrine disruptors can mimic, block or disrupt the production, transport, elimination or regulation of natural hormones which can lead to adverse health effects such as developmental abnormalities, cancers and reproductive problems.
Since 2018, it has been mandatory to evaluate substances for their potential to cause Endocrine Disruption (ED) under the Plant Protection Products and Biocide Products regulations.
The year 2023 is a crucial moment as the CLP regulation has introduced new hazard classes for ED, which were initially introduced in December 2022 with an effective date of 20 April 2023:
Category 1: Known or presumed endocrine disruptors for human health and/or for the environment. For this category, the limit concentration is 0,1% in the mixture. This implies new hazard statements:
Category 2: Suspected endocrine disruptors for human health and/or for the environment. For this category, the limit concentration is 1% in the mixture. The relevant new hazard statements are:
Furthermore, other substances are classified as PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative), PMT (persistent, mobile, toxic), and vPvM (very persistent, very mobile). The mixture is classified when at least one compound is classified and is present at 0.1%. This also implies new hazard statements accordingly:
Manufacturers, importers, downstream users, and distributors placing substances on the European Union market are bound by this EU legislation. Member States will also refer to the new hazard classes and criteria when making proposals for harmonized classification and labelling.
From April 20th 2023, Member States can propose harmonized classification and labelling with the new hazard classes, and manufacturers, importers, downstream users, and distributors can self-classify their substances and mixtures accordingly. However, there are transitional periods, during which the new hazard classes are not yet mandatory but based on voluntary action.
For new substances on the market, companies need to comply with the new rules from May 1st 2025, while substances that have already been on the EU market must comply by November 1st 2026. Separate transition times apply for mixtures, with new hazard classes applying from May 1st 2026 for new mixtures, and companies having until 1 May 2028 to update the classification and labeling for existing mixtures on the EU market.
Furthermore, the update of regulations on Cosmetic Products to take into account ED assessment is expected in the forthcoming months, and the next update of the REACH regulation is anticipated to include new requirements to identify ED from the lowest tonnage band by the end of this year or the beginning of the next.
Check out our timeline on Substances:
Mixtures:
Take action now to ensure accurate classification, labeling, and packaging of your products! If you require assistance with endocrine disruptor (ED), persistent, bioaccumulative, and toxic (PBT), or very persistent and very bioaccumulative (PMT) assessments, we are here to help.
Our team can review the formulas of your products and update their classifications based on the presence of ED/PBT/PMT substances. Don't compromise on compliance contact us today to verify your classifications and make necessary updates.
An endocrine disruptor is a substance (chemical, natural, drug,...) that can interfere with the body's endocrine system. These substances interfere with natural hormones that regulate functions such as growth and development, metabolism and reproduction by three main mechanisms.
Endocrine disruptors can mimic, block or disrupt the production, transport, elimination or regulation of natural hormones which can lead to adverse health effects such as developmental abnormalities, cancers and reproductive problems.
Since 2018, it has been mandatory to evaluate substances for their potential to cause Endocrine Disruption (ED) under the Plant Protection Products and Biocide Products regulations.
The year 2023 is a crucial moment as the CLP regulation has introduced new hazard classes for ED, which were initially introduced in December 2022 with an effective date of 20 April 2023:
Category 1: Known or presumed endocrine disruptors for human health and/or for the environment. For this category, the limit concentration is 0,1% in the mixture. This implies new hazard statements:
Category 2: Suspected endocrine disruptors for human health and/or for the environment. For this category, the limit concentration is 1% in the mixture. The relevant new hazard statements are:
Furthermore, other substances are classified as PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative), PMT (persistent, mobile, toxic), and vPvM (very persistent, very mobile). The mixture is classified when at least one compound is classified and is present at 0.1%. This also implies new hazard statements accordingly:
Manufacturers, importers, downstream users, and distributors placing substances on the European Union market are bound by this EU legislation. Member States will also refer to the new hazard classes and criteria when making proposals for harmonized classification and labelling.
From April 20th 2023, Member States can propose harmonized classification and labelling with the new hazard classes, and manufacturers, importers, downstream users, and distributors can self-classify their substances and mixtures accordingly. However, there are transitional periods, during which the new hazard classes are not yet mandatory but based on voluntary action.
For new substances on the market, companies need to comply with the new rules from May 1st 2025, while substances that have already been on the EU market must comply by November 1st 2026. Separate transition times apply for mixtures, with new hazard classes applying from May 1st 2026 for new mixtures, and companies having until 1 May 2028 to update the classification and labeling for existing mixtures on the EU market.
Furthermore, the update of regulations on Cosmetic Products to take into account ED assessment is expected in the forthcoming months, and the next update of the REACH regulation is anticipated to include new requirements to identify ED from the lowest tonnage band by the end of this year or the beginning of the next.
Check out our timeline on Substances:
Mixtures:
Take action now to ensure accurate classification, labeling, and packaging of your products! If you require assistance with endocrine disruptor (ED), persistent, bioaccumulative, and toxic (PBT), or very persistent and very bioaccumulative (PMT) assessments, we are here to help.
Our team can review the formulas of your products and update their classifications based on the presence of ED/PBT/PMT substances. Don't compromise on compliance contact us today to verify your classifications and make necessary updates.