Endocrine Disrupting Chemicals (also referred to as hormone disruptors or EDCs) are synthetic chemicals that are not produced by the human body and that disrupt the normal functioning of humans and animals.
It is suspected that EDCs can cause decreased fertility, hormone-related cancers, behavioral changes, adverse effects on the immune systems, and metabolic disorders.  Such adverse effects could be mediated by mimicking the body’s own hormones or interfere with hormone production, secretion, degradation or transport of hormones in the body.
EDCs are suspected of being capable of acting even at very low doses and sensitive windows of exposure appear to be during critical periods of development (for instance, fetal development and puberty).
The harmful impact that EDCs have on health and the environment has been known for more than 20 years.

On 20 September 2022 the European Commission published a Draft delegated regulation introducing new hazard classes to the system established in Regulation (EC) 1272/2008, on the classification, labelling and packaging of substances and mixtures (the CLP Regulation). 

The Draft regulation would introduce the following new hazard classes and categories:  

Endocrine disruptors for human health, category 1 (known or presumed) and category 2 (suspected) 
Endocrine disruptors for the environment, category 1 (known or presumed) and category2 (suspected)  
Persistent, Bio-accumulative and Toxic (PBT) or very Persistent, very Bio-accumulative (vPvB) substances  
Persistent, Mobile and Toxic (PMT) or very Persistent, very Mobile (vPvM) substances  

The regulation includes the classification criteria for substances and mixtures, as well as the relevant labelling elements, including new hazard statements.  For PBT/vPvB substances, common criteria are established for persistence and bioaccumulation. However, given their difference in toxicity, they remain different categories. The same situation applies to PMT/vPvM substances. 

The new classification and labelling requirements would apply to substances 18 months after the regulation’s entry into force. In the case of mixtures, the transitional period would be 36 months.

However, the draft establishes grace periods for substances and mixtures labelled before the entry into force and placed on the market before the end of the transitional period. The old classifications may continue to apply for 42 months for substances and 60 months for mixtures. 

While still a draft, the introduction of new hazard classes and categories in the CLP Regulation is a key development in chemicals management worldwide. As many countries around the world seek to adopt both the GHS and REACH-like regulations, this development opens space for divergence between the global and EU frameworks. Additionally, it is related to the upcoming revision of EU Regulation 1907/2006 (the REACH Regulation), as the Chemicals Strategy for Sustainability pointed to the categorization of endocrine disruptors, PMT and vPvM substances as substances of very high concern (SVHC) under REACH. 

In addition to these developments through delegated regulations, further changes to chemicals management in Europe are expected in the coming months, when the European Commission proposes amendments to the REACH and CLP Regulations themselves. 

Once adopted by the Commission, delegated acts enter into force automatically unless the European Parliament or the Council of the EU explicitly oppose them. The current draft is open for public comments until October 18, 2022.  



More News
ECHA Adds Five Hazardous Chemicals To PIC
News · 08/09/2023

The European Chemicals Agency (ECHA) has amended the Prior Informed Consent (PIC) Regulation, EU 64/2012, to add 27 pesticides and eight industrial chemicals into Annex I, bringing the total to 295. As a result, EU exporters are now required to notify their intentions to export them from 1 November onwards.

Global Custom Synthesis & Manufacturing: Escalating Demand for Specialty Chemicals Drives Growth
News · 04/09/2023

The global custom synthesis and manufacturing market was valued at US$271.33 billion in 2022. The market value is expected to reach US$474.94 billion by 2028.

4 key Trends Reshaping Ocean freight Industry in 2023
News · 04/04/2023

The ocean freight industry is undergoing a massive transformation, as the technology and supply chain management tools are being improved by the day, impacting ocean freight rates.

What do China’s data export regulations mean for its trade competitiveness?
News · 13/12/2022

In the second half of 2022, China unveiled the details of its data export regulations, providing further explanations to its existing laws and regulations on data.

Energy Crisis: The EU Chemical Industry Is Reaching Breaking Point
News · 11/11/2022

The current energy crisis has reached an unsustainable level for the European chemical industry. For the first time ever, the EU imports more chemicals than it exports, both in volume and value, resulting in a trade deficit of € 5.6 bn for the first half of 2022.

The Shipping Industry in a downward spiral
News · 03/10/2022

The shipping industry is now returning to normality and is in a downward spiral. The cost of shipping goods from China has slumped to the lowest level in more than two years as the world economy stumbles, dimming prospects for container carriers that turned in record profits during the pandemic.

Global Freight Situation
News · 08/09/2022

No precipitous plunge in container shipping rates, just ‘orderly’ decline.

3 Key Insights into the Global Food and Beverage Market
News · 02/08/2022

The global food and beverage market size is expected to grow from $5.8 trillion in 2021 to $6.4 trillion in 2022 at a growth rate of 9.7%. The food and beverage market size is expected to grow to $8.9 trillion in 2026 at a compound annual growth rate of 8.7%.

News · 01/07/2022

The amendment makes QR codes mandatory on every active pharmaceutical ingredient. The Amendment Rules will come into force from January 01, 2023.