How chemicals can affect the health of developing children

There is an increased concern about endocrine-disrupting chemicals, especially their interference on the thyroid gland

The impact of such chemicals on thyroid hormone levels, especially those of pregnant women during the first three months of pregnancy, may result in neurodevelopmental diseases, autism and IQ loss in the unborn child.

Barbara Demeneix, Professor from the French National Museum of Natural History, explains why these chemicals affect the signalling of thyroid hormones and what we can do to protect our children.

Video published on 7 February 2018, by EUchemicals.

The field of microplastics

Adding microplastics to products is irresponsible since sustainable alternatives already exist

Watch interviews with leading experts and researchers in the field of microplastics as well as representatives from environmental NGOs and industry who explain their concerns with the use of plastic in our society.

Video published on 25 January 2019, by EUchemicals.

Microplastics restriction, a step forward, but when will the EU ban their use ?

Is the EU taking the first step to completely phase out microplastics ?

Zero Waste Europe, Press Release, Brussels 30/01/2019

Abstract

“The EU will use its powerful chemical laws to stop most microplastics and microbeads being added to cosmetics, paints, detergents, some farm, medical and other products, according to a draft law due to be tabled today.” …

… “The restriction is expected to become law across Europe by 2020. It will prevent an estimated 400,000 tonnes of plastic pollution, the agency says. NGOs welcomed the move as a significant step forward, but strongly warn that it grants unnecessary delays for most industrial sectors and excludes some biodegradable polymers. As it stands, the draft law will only restrict one sector when it comes into force, namely cleansing products made by firms that have already pledged to stop using microplastic. Other sectors will be granted 2-6 years before the law takes effect. The proposal will go to public consultation this summer followed by economic, social and risk assessments, then a vote by government experts in the secretive REACH committee not before early 2020.” …

Read EU moves to ban microplastics in most products, ECHA’s proposal, ECHA’s annex and press release.

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Bisphenol A becomes officially recognised as an endocrine disruptor

Bisphenol A is recognised by ECHA for its endocrine-disrupting properties, based on a proposal by France

Member State Committee unanimously agrees that Bisphenol A is an endocrine disruptor

ECHA/PR/17/12 – The Member State Committee (MSC) supported the French proposal to additionally identify Bisphenol A as a substance of very high concern because of its endocrine disrupting properties which cause probable serious effects to human health. The committee also agreed to identify the substance PFHxS as an SVHC.

Helsinki, 16 June 2017 – The Member State Committee (MSC) unanimously agreed on the identification as substances of very high concern (SVHCs) of:

  • 4,4′-isopropylidenediphenol (bisphenol A, BPA) (EC 201-245-8, CAS 80-05-7), proposed by France, due to its endocrine disrupting properties for human health;
  • Perfluorohexane-1-sulphonic acid and its salts (PFHxS), proposed by Sweden, due to their very persistent and very bioaccumulative (vPvB) properties.

Bisphenol A is already listed in the Candidate List due to its toxic for reproduction properties. At the MSC meeting earlier this week, MSC unanimously agreed on its additional identification as an SVHC because of its endocrine disrupting properties which cause probable serious effects to human health which give rise to an equivalent level of concern to carcinogenic, mutagenic, toxic to reproduction (CMRs category 1A or 1B) substances.

ECHA will include PFHxS in the Candidate List and will update the current entry for BPA accordingly by the end of June 2017. Companies may have legal obligations with respect to these substances upon publication of the updated Candidate List.

Bisphenol A is recognised by ECHA for its endocrine-disrupting properties, based on a proposal by France

In February 2017, ANSES submitted a proposal to the European Chemicals Agency (ECHA) to classify bisphenol A (BPA) as a substance of very high concern (SVHC) within the framework of the European REACh regulation, based on its “endocrine-disrupting” properties which cause probable serious effects to human health. This proposal has just been adopted by ECHA’s Member State Committee. The decision means that industry players must notify ECHA of the presence of bisphenol A in all imported or manufactured items and must also inform buyers when items contain the substance. The inclusion of BPA on ECHA’s list of substances of very high concern also means that it may be submitted to authorisation as a substance, with its uses subject to the granting of a temporary, renewable authorisation.

Bisphenol A is a synthetic chemical which has been used for over 50 years, mainly in the plastics industry. ANSES has identified close to sixty business sectors that are potential users of the substance in France. Studies by ANSES on the uses and health effects of bisphenol A, conducted as part of the National Endocrine Disruptor Strategy, led the Agency to recommend, as of September 2011, a reduction in population exposure to the substance through its substitution in food contact materials in particular. Therefore since 1 January 2015 bisphenol A has been banned in food containers in France, and has led to a significant reduction in exposure levels.

Furthermore, in 2012, in the framework of implementation of the European regulation on the labelling of chemical substances (CLP regulation), ANSES submitted a proposal to ECHA for amending the classification of bisphenol A in order to include it in category 1B – substances toxic to reproduction (fertility). This proposal was adopted by the European Commission in July 2016.

Following this, a measure restricting BPA use in certain widely available items such as receipts made of thermal paper, was also adopted by the European Commission in December 2016, based on a dossier filed by ANSES with ECHA as part of the REACh regulation.

Identification of bisphenol A as a substance of very high concern

The REACh regulation specifies that substances that may have serious and often irreversible effects on human health and the environment can be identified as substances of very high concern (SVHC). In February 2017, ANSES submitted a proposal to ECHA for identifying BPA as an SVHC based on its “endocrine disrupting” properties which cause probable serious effects to human health.

This proposal has just been adopted by the Member State Committee of ECHA. As a direct result of BPA’s identification as an SVHC, industry players will now have to notify ECHA of the presence of bisphenol A in all imported or manufactured items and must also inform buyers, upon request, when items contain the substance.

BPA’s inclusion on the list of substances of very high concern means that its uses may be limited and subject to the granting of a temporary, renewable authorisation.

Sources
  • MSC unanimously agrees that Bisphenol A is an endocrine disruptor, ECHA, 16 June 2017.
  • Bisphenol A is recognised by ECHA for its endocrine-disrupting properties, based on a proposal by France, ANSES, 16/06/2017.
  • Image credit Percy.

Evaluations Applied to Glyphosate Data are Scientifically Flawed and Fail to Protect Public Health

Open Letter from Dr. Christopher Portier, Cancer Expert, on His Review of the Carcinogenicity of Glyphosate European Union Authorities

The President of the European Commission, Jean-Claude Juncker, has received an embarrassing letter last Monday 29 May, 2017.

Christopher Portier, world-renowned toxicologist and biostatistician, former director of several US federal research institutions, has had access to data from confidential studies on glyphosate – those transmitted by industrialists to European authorities. He discovered information that had gone so far unnoticed.

Executive Summary

The European Food Safety Agency IEFSA) and the European Chemical Agency IEChA) have completed their assessments of the carcinogenic potential of glyphosate and concluded that the evidence does not support a classification for glyphosate.

The raw data for the animal cancer studies for glyphosate have been released, and a reanalysis of these data show eight instances where significant increases in tumor response following glyphosate exposure were not included in the assessment by either EFSA or EChA.

This suggests that the evaluations applied to the glyphosate data are scientifically flawed, and any decisions derived from these evaluations will fail to protect public health.

I ask that the evaluations by both EFSA and EChA be repeated for all toxicological endpoints and the data underlying these evaluations be publicly released.

Christopher Portier,
Former Director US National Center for Environmental Health
Former Director US Agency for Toxic Substances and Disease Registry
Former Associate Director, US National Institute of Environmental Health
Sciences
Former Associate Director US National Toxicology Program
Fellow, American Statistical Association
Fellow, International Statistics Institute

Is Glyphosate Carcinogenic ? It’s All Good says the European Chemicals Agency !

Glyphosate not classified as a carcinogen by ECHA, March 2017

Helsinki, 15 March 2017 – The European Chemicals Agency (ECHA)’s Committee for Risk Assessment (RAC) assessed glyphosate’s hazardousness against the criteria in the Classification, Labelling and Packaging Regulation. They considered extensive scientific data in coming to their opinion.

The committee concluded that the scientific evidence available at the moment warrants the following classifications for glyphosate according to the CLP Regulation:

  • Eye Damage 1; H318 (Causes serious eye damage)
  • Aquatic Chronic 2; H411 (Toxic to aquatic life with long lasting effects)

RAC concluded that the available scientific evidence did not meet the criteria in the CLP Regulation to classify glyphosate for specific target organ toxicity, or as a carcinogen, as a mutagen or for reproductive toxicity.

ECHA’s Committee for Risk Assessment (RAC) agrees to maintain the current harmonised classification of glyphosate as a substance causing serious eye damage and being toxic to aquatic life with long-lasting effects.

RAC concluded that the available scientific evidence did not meet the criteria to classify glyphosate as a carcinogen, as a mutagen or as toxic for reproduction.

The hazard classes for which classification was proposed by the German competent authority were specific target organ toxicity (repeated exposure) (category 2), eye damage/irritation (category 1), and toxicity to the aquatic environment (Aquatic Chronic 2).

ECHA also assessed other hazard classes including carcinogenicity, germ cell mutagenicity and reproductive toxicity.

The adopted opinion will go through a normal editorial check before it is sent to the European Commission. The opinion will also be made available on ECHA’s website at the same time.

The adopted opinion on the harmonised classification for glyphosate will be taken into account when the Commission and Member States consider whether to renew the approval to use glyphosate as an active substance in pesticides, later this year.

Background

Apart from the published studies on glyphosate, the committee also had full access to the original reports of studies conducted by industry. RAC has assessed all the scientific data, including any scientifically relevant information received during the public consultation in summer 2016.

RAC had a first discussion on glyphosate with stakeholders at its 39th meeting in December 2016.

RAC provides an independent scientific opinion on the hazard classification of the substance. The classification is based solely on the hazardous properties of the substance. It does not take into account the likelihood of exposure to the substance and therefore does not address the risks of exposure. The risks posed by exposure are considered for example when deciding whether to renew the approval of glyphosate as a pesticide in accordance with the EU’s Plant Protection Product Regulation (Regulation (EC) N° 1107/2009).

The European Chemicals Agency’s role in the EU-wide classification of glyphosate

What is happening with glyphosate in the EU?

Video published on 7 February 2017 by EUchemicals.

Glyphosate is one of the most widely used substances in pesticides. The authorisation for using it in the EU has expired and authorities are deciding whether to renew it for a further 15 years.

The European Commission has in the meantime extended the authorisation temporarily until the end of 2017 while waiting for the classification of the substance by the European Chemicals Agency (ECHA).

Corporate Europe Action

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EurActiv Statement

Read the press release here.

HEAL Campaign

Join the initiative here.

Science Mag Position

Read the press release here.

EDCs, Pesticides and EU Lobbying…
  1. The Manufacture of a Lie.
  2. A Denial of the State of the Science.
  3. The Interference of the United States.
  4. The Discreet but Major Gift to the Pesticides Lobby.

162 chemical substances shortlisted by the European Chemicals Agency for possible regulatory action

Image credit ECHA, shows what EU action has been taken since previous screenings of substances

Helsinki, 12 January 2017 – The European Chemicals Agency (ECHA) has selected 162 substances from REACH registrations for further scrutiny by the Member State competent authorities in its annual IT screening exercise. The competent authorities will carry out a manual examination of the dossiers they prioritise to decide whether regulatory action is needed.

The selection is based on an automated IT screening focusing on substances with potential carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), endocrine-disrupting, sensitising or specific target organ toxicity following repeated exposure (STOT RE) properties.

Potential substances with these hazardous properties were then further prioritised based on uses that are likely to lead to exposure to humans or release to the environment. The Member State competent authorities will select substances from the shortlist for their manual examination.

If your company has registered one of substances now shortlisted, you will receive a letter from ECHA informing of the potential examination of your registration(s). We encourage you to update your dossiers to address any shortcomings as soon as possible. Up-to-date information will help the Member State authorities better assess whether the concern indicated by the screening is confirmed, and whether regulatory action is still needed.

You are also invited to a webinar taking place on 14 February. In this webinar, you will get more details about the screening process. You will also have the opportunity to ask questions from ECHA’s staff.

If the Member States or ECHA take actions on your substance, this information will be published on the Agency’s website, for example, in the list of substances potentially subject to compliance checks, the Registry of Intentions (RoI), the draft Community rolling action plan for substance evaluation, and the the Public Activities Coordination Tool (PACT). You can check the status of your substance through the Search for chemicals available on ECHA’s homepage.

ECHA does not make the list of shortlisted substances public as it is purely based on automated selection by IT and manual verification is needed to confirm a potential concern.

Background

ECHA and the Member State competent authorities conduct IT and manual screening annually as part of the common screening approach. The aim is to identify substances that pose a risk for human health or the environment and take them forward to the most appropriate REACH and CLP processes to ensure their safe use. The common screening approach is part of the SVHC Roadmap to 2020 implementation plan.

The previous three rounds of IT screening have identified altogether 893 substances for further scrutiny. Of those, Member States have examined 581 substances. 78 % required follow-up activities with some substances having more than one outcome. See the feature image above for more information.

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BPA among new substances of very high concern

EU names bisphenol-A among new SVHCs

Helsinki, 12 January 2017 – The European Chemicals Agency (ECHA) has added four new SVHCs to the Candidate List – now containing 173 substances, including BPA – based on proposals by France, Sweden, Germany and Austria, following the SVHC identification process with involvement of the Member State Committee.

The European Chemicals Agency is the driving force among regulatory authorities in implementing the EU’s groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness. ECHA helps companies to comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern.

The Candidate List is a list of substances that may have serious effects on human health or the environment. Substances on the Candidate List are also known as “substances of very high concern“. The aim of publishing such a list is to inform the general public and industry that these substances are candidates for possible inclusion in the Authorisation List. Once they are on the Authorisation List, industry will need to apply for permission to continue using the substance after the sunset date.

Regarding bisphenol A (BPA) , the reason for inclusion was : “Toxic for reproduction“(Article 57c).

Companies may have legal obligations resulting from the inclusion of the substance in the Candidate List. These obligations may apply to the listed substance on its own, in mixtures or in articles. In particular, any supplier of articles containing a Candidate List substance above a concentration of 0.1% (weight by weight) has communication obligations towards customers down the supply chain and consumers. In addition, importers and producers of articles containing the substance have six months from the date of its inclusion in the Candidate List (12 January 2017) to notify ECHA. Information on these obligations and related tools are available on the ECHA website.

Endocrine disruptors: EFSA and ECHA outline Guidance plans

How to identify substances with endocrine disrupting properties in pesticides and biocides

EFSA and the European Chemicals Agency (ECHA) have published an outline of the Guidance they are developing on how to identify substances with endocrine disrupting properties in pesticides and biocides.

The outline includes a projected table of contents, as well as a plan of the drafting process, including timelines, responsibilities, consultations with relevant parties and an explanation of how the document will be endorsed.

The Guidance will enable applicants and regulatory authorities to identify endocrine disruptors among chemical substances proposed as pesticides and biocides using hazard-based scientific criteria currently being finalised by EU Member States and the European Commission.

The Guidance is to be drafted by a joint team of scientific staff from ECHA and EFSA, supported by the European Commission’s Joint Research Centre. Minutes of meetings of this drafting group will be published.

Endocrine disruptors: EFSA and ECHA outline Guidance plans, European Food Safety Authority, 20 December 2016.

Additional support to the group will be provided by a specially constituted Consultation Group, which will include members of ECHA’s Endocrine Disruptors Expert Group, and pesticide experts from EU Member States and other stakeholder groups. The drafting group may also consult other scientific bodies, such as EFSA’s Scientific Committee or its Panel on Plant Protection Products and their Residues (PPR) and this panel’s working groups.

A public consultation on the draft Guidance is scheduled for the summer of 2017.

More Information

  • Outline of draft Guidance for the implementation of hazard-based criteria to identify endocrine disruptorsefsa.europa.eu, 16 December 2016.
  • Request from the European Commission, ec.europa.eu, 17/10/2016
  • Minutes of joint EFSA/ECHA/JRC kick-off meeting on endocrine disruptors guidance, efsa.europa.eu.
  • European Commission’s proposed criteria for endocrine disruptors, ec.europa.eu.