Article

Endocrine Disrupting Chemicals (EDC) in EU Chemical Regulations

Posted on: July 26, 2017

by Tatjana Benko

Endocrine Disrupting Chemicals (EDC) are chemicals which have an impact on the endocrine system of humans and animals. EDCs were defined for the first time in 2002 by the International Programme for Chemical Safety (IPCS) as “exogenous substances that alter function(s) of the endocrine system and consequently cause adverse health effects in an intact organism or its progeny, or (sub)populations”.

“The endocrine system is a complex network of glands, hormones and receptors.” Endocrine glands (e.g., pineal gland, pituitary gland) secrete hormones into the blood that are carried to distant target organs with specific cellular receptors and in this way, the endocrine system controls the development, reproduction, metabolism, immunity and behavior of humans and animals.

EDCs can disrupt the function of natural endocrine systems by modifying, stimulating or inhibiting the hormones’ signals, mimicking hormones or interfering with hormone action(s), all of which cause harmful effects to human and animal health.

EDCs are present in many commonly used products, including plastics, electronics, textiles, packaging, clothing, cosmetic products, pesticides, biocides, etc. And many of them can accumulate in humans and the environment. Human exposure to EDCs is caused by ingestion of food and water, by inhalation and by absorption through the skin.

EDCs are related to many growing health disorders including infertility, risk of miscarriage, obesity, endocrine related cancers (breast, ovarian, thyroid and prostate cancers) and neurological disorders such as autism and ADHD (attention deficit hyperactivity disorder).

EXAMPLES OF POTENTIAL ENDOCRINE DISRUPTORS, per the World Health Organization (WHO):

  • Polychlorinated dioxins and PCBs (Polychlorinated biphenyls) are linked to breast cancer;
  • Pesticides, some PCBs and arsenic are linked to prostate cancer risks;
  • PCBs are linked to early puberty and negative impacts on brain development;
  • Organophosphate pesticides are linked to ADHD;
  • DDT (Dichlorodiphenyltrichloroethane), is associated with early pubert+-y, reduced fertility in daughters of exposed women, and increased breast cancer risks;
  • Some phthalates were banned in children’s products from 2008 because studies link them to premature thelarche;
  • POP (Persistent Organic Pollutants) manufactured chemicals persist for years in environment and can cause many health disorders.

EDCs have complex and multiple effects (end-effect may be functional change) and they require special scientific criteria for identifying. That was the major reason why EDCs were not regulated for so many years.

REGULATIONS

Under the REGULATION (EC) No 1907/2006, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), EDC properties are included as a reason to identify a substance as a Substance of Very High Concern (SVHC). Several substances have already been identified and listed on the Candidate List of Substances of Very High Concern for Authorisation. One typical example is Bisphenol A (BPA). BPA was originally added to the Candidate List for Authorisation as a reprotoxic substance and recently the endocrine disruptor properties for human health have been added to the reason of inclusion.

On June 13, for the first time, two substances groups, due to their endocrine disrupting effects to the environment according to Article 57(f) of REACH, were added to the Authorisation list (REACH Annex XIV). These two groups are:

  • ‘The substance group 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated (covering well-defined substances and substances of unknown or variable composition, complex reaction products or biological materials (‘UVCB substances’), polymers and homologues);
  • The substance group 4-nonylphenol, branched and linear, ethoxylated (including substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof)’

The new EU Medical Device Regulation (EU) 2017/745 includes specific thresholds for EDCs in the production and design of devices in medical industry.

In addition, EU legislation on pesticides and biocides regulate substances with endocrine disrupting properties. Per Regulation (EC) No 1107/2009, an approval for using an active substance in a plant protection product can be rejected on the basis of ED properties. However, to reject a substance due to ED properties, an official definition is needed to identify this hazard. In early July 2017, EU member’s states voted in favor of the European Commission’s proposal on scientific criteria to identify endocrine disruptors.

{ Recommended Action Items }

  • Review the proposed scientific criteria.
  • Review your list of substances to determine if your company uses EDCs and/or potential EDCs.
  • Search for safer alternatives and consider replacing EDCs in your company processes and in the final products.
  • Submit to ECHA, via a REACH registration dossier, all available scientific information about harmful substances, especially if there is any doubt on possible effects on the endocrine system.

References and Resources:

Commission Regulation (EU) 2017/999

European Commission – Press release “Endocrine disruptors: major step towards protecting citizens and environment” (4 July 2017)

European Chemicals Agency (ECHA) – Endocrine Disruptor Expert Group

World Health Organization (WHO), Endocrine Disrupting Chemicals (EDCs) 

Medical Device Regulation (EU) 2017/745

 


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