REACH Registration final deadline: 21 551 chemicals on EU market registered by 31 May 2018
On 31 May 2018 the 10-year period for registering existing chemicals under EU's Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) has finished. 13 620 European companies have submitted information to the European Chemicals Agency (ECHA) on 21 551 chemicals manufactured or imported in the EU and EEA at above one tonne a year.
The REACH registration process closed the knowledge gap that existed prior to the regulation on the number of chemicals on the EU market, their uses, their hazards and their risk management. The European Chemicals Agency (ECHA) checks the information coming from registration dossiers for both completeness and compliance with the registration requirements, and the data is used for the establishment of a complete database that is accessible for free to everybody for consultation of non-confidential information.
Since the adoption of REACH in December 2006, the EU has established a fair and transparent internal market for chemicals with strict safety rules. REACH aims to ensure a high level of protection of human health and the environment from the risks that can be posed by chemicals. REACH also ensures the free circulation of chemicals on the internal market, while enhancing the competitiveness of EU industry and promoting innovation, and it promotes alternatives to animal testing for the hazard assessment of chemicals.
In 2007 REACH was adopted based on the ‘no data, no market’ principle, making industry responsible for the safety of chemicals along the supply chain, To continue their business, the chemicals industry had to describe the impact on human health and the environment of the chemicals they manufacture and import, and manage the risks they pose. The proof that chemicals can be used safely should be submitted to ECHA in registration dossiers documenting the chemicals’ properties, uses, and conditions for safe use. Information on how to use chemicals safely should also be communicated to the users further in the supply chain.
The chemicals manufactured or imported in high volumes (> 1 000 tonnes per year) were registered in 2010, those in the middle volumes (100 to 1 000 tonnes per year) in 2013 and the small-volume chemicals (1 to 100 tonnes per year) by 31 May 2018.
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REACH: Member States vote for more clarity in nanomaterials registrations and for restricting the use of hazardous chemicals in textiles
In a vote in the REACH Committee on 26 April, Member States agreed to amend several Annexes to REACH clarifying REACH registration requirements with regard to nanomaterials. Member States also endorsed Commission action to protect consumers' health against chemicals known to cause cancer and reproductive health problems, in a vote to ban the use of these hazardous chemicals in clothing, textiles and footwear.
REACH has always applied to nanomaterials, but did not contain specific provisions for them, which is why companies often did not know how to register substances in nanoform. The specific requirements will address the current knowledge gap on which substances registered under REACH are placed on the market as nanomaterials and in which quantities. They will also provide information on their basic characteristics, use, how to handle them safely, what risks they potentially pose to health and the environment and how these risks can be adequately controlled. The draft Commission Regulations with the revised annexes will now be submitted for a 3-month scrutiny by the European Parliament and Council before being adopted by the European Commission.
Under REACH, all manufacturers and importers of chemicals have a general obligation to register to the European Chemicals Agency each substance manufactured or imported in quantities of 1 tonne or more per year per company (legal entity). In the registration dossier, they must identify the risks that are linked to the substances they produce and market and indicate how these risks are managed.
CMRs in textiles:
The CMR (Carcinogenic, Mutagenic or Toxic for reproduction) substances to be banned under REACH in the Commission proposal may be present in clothing, textiles, and footwear either from the production process or because they have been added intentionally to give specific properties such as to prevent shrinkage or make fabric crease-resistant. Consumers can be exposed to these hazardous substances through skin contact, inhalation or unintentional ingestion of dust released from the textile fibres. Small children are also at risk due to a possible oral exposure.
The Commission proposes to limit the exposure to 33 CMR chemicals by restricting the placing on the market of containing them. As from the entry into force of the restriction, clothing and related articles, textiles and footwear containing the listed substances, whether they are produced within the EU or imported into the EU, are not allowed to be placed on the EU market. The proposal follows discussions with relevant stakeholders, in particular citizens, public authorities, industry and trade associations, NGOs and Member States' representatives. After scrutiny by the Parliament and Council and after publication in the Official Journal of the EU, it will become applicable in the following 24 months.
Restrictions are regulatory measures to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions may limit or ban the manufacture, placing on the market or use of a substance. A restriction can apply to any substance on its own, in a mixture or in an article, including those that do not require registration. Restrictions setting out conditions for the placing on the market of substances apply to both domestic production and imports.
REACH: Toxic flame retardant decaBDE restricted
On 9 February 2017 the REACH restriction of the brominated flame retardant decaBDE was published in the Official Journal.
This means that decaBDE can no longer be produced, placed on the market or used in the EU, with some exceptions as specified in the Official Journal. DecaBDE is a flame retardant widely used in domestic and commercial plastics and textile articles, including interiors and upholstery (carpets, furniture, seating and plastic components). It is also used in the transport, building and mining sectors for roofing, insulation, piping and in cables.
The reason for acting on decaBDE is that it occurs widely and accumulates in the environment and in wildlife, creating a high potential for long-term (lifetime) exposure to decaBDE and to a variety of its hazardous transformation products which may result in developmental neurotoxicity in mammals, including in humans and the unborn child.
DecaBDE is also known for its global distribution through the atmosphere. Therefore it is currently being considered for listing under the Stockholm Convention for persistent organic pollutants (POPs) – an international treaty that requires countries to eliminate or restrict its listed substances.
REACH and alternatives to animal testing: new rules for skin sensitisation and skin corrosion/irritation tests
The European Commission has amended REACH annexes to replace in-vivo tests by in vitro or in chemico, for the testing of chemical substances for skin corrosion/irritation, serious eye damage/eye irritation and acute toxicity and for skin sensitisation.
The amendments reflect the significant scientific progress made in recent years in the development of non-animal test methods. The amendments are timely and will significantly reduce the amount of animal tests needed in the run up to meet the last REACH registration deadline in 2018.
The new requirements for skin and eye irritation replace the standard animal studies by in vitro data. Animal studies should only be needed in exceptional cases where in vitro tests are not suitable. In another change to the Annexes, there will be no longer a need to perform an additional dermal test for substances that did not show acute toxicity in oral tests.
The amendment for the testing for skin sensitisation acknowledges that the newly developed in vitro studies can be used for the purpose of registering a substance under REACH, if these tests provide an equivalent level of information on the sensitisation potential and strength of a substance as the standard animal test.
The European Chemicals Agency (ECHA) is in the process of adapting the relevant guidance for applying the new rules.
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The public consultation on a possible restriction of hazardous substances (CMR 1A and 1B) in textile articles and clothing for consumer use under Article 68(2) of Regulation EC No 1907/2006 (REACH) has closed. For the results click here.
REACH: new method to test chemicals for adverse effects on reproduction
By an amendment to REACH Annexes IX and X, the extended one-generation reproductive toxicity study (EOGRTS) becomes the standard information requirement for reproductive toxicity. It replaces the two-generation reproductive toxicity study.
In most cases, EOGRTS uses significantly less animals compared to the old test. EOGRTS produces more information compared to the old test, in particular on the potential of a chemical to affect the endocrine system. By including additional modules in the test, further investigations on the possible neurotoxicity or immunotoxicity of a chemical are possible.
The change in test methods concerns data produced for the purpose of REACH, but the data will also be useable under other regulatory schemes (e.g. biocides, pesticides).
EOGRTS contributes to the REACH aims of ensuring a high level of protection of human health and the environment and of promoting alternative test methods, as well as to the 3R's principle in animal testing (Replace, Reduce, and Refine).
Commission improves safety of consumer detergents
The Commission has adopted a Regulation on additional safety measures for liquid laundry detergents in soluble capsules. This is in response to recent poisonings of young children in the EU due to handling such capsules. These poisoning incidents occurred more often and were more serious than incidents with detergents in traditional packaging.
The proposal aims to reduce the number and the severity of poisonings through additional requirements: to include a bittering agent on the soluble film to deter children from putting the capsule into their mouth and to make the packaging more difficult to open for children. In addition, the packaging is to display warnings to alert parents and child-care providers that such products have to be kept out of reach of children.
The detergents industry will complement this initiative with a voluntary programme on raising awareness and applying measures to all detergents in soluble packaging. The Commission is also leading a global awareness activity at OECD level on the risks posed by liquid laundry detergents capsules.
Figure 1: Some examples of Liquid laundry detergent capsules
Commission consults the public on criteria to identify Endocrine Disruptors
The European Commission has launched an on-line consultation to help define criteria for endocrine disruptors as required by the regulations on biocidal and plant protection products. Endocrine disruptors are chemicals that interfere with hormone systems, which may lead to harmful effects on health and the environment. Input is sought from stakeholders and the public on various options for the criteria and for their implementation.
Chemicals with endocrine disrupting properties are used in various industrial and service sectors, and may be found in the environment after their use. Current legislation for biocidal products and plant protection products requires the Commission to specify scientific criteria for the determination of endocrine-disrupting properties of chemical substances. Because of the potential socio-economic impacts linked to how the criteria will be defined and the complexity of the issue, the Commission needs to carry out an impact assessment, and to consult the public. The scope of the impact assessment is set out in a roadmap. Until the new criteria are set, protective interim criteria are in place.
All citizens and organisations are invited to contribute to the consultation which will be open until 16 January 2015. Replies to the public consultation will, subject to confidentiality rules, be published following the closure of the consultation.
For more information:
The public consultation can be found at: http://ec.europa.eu/yourvoice/
Commission grants first REACH authorisation
On 7 August 2014 the European Commission granted the first authorisation under REACH to Rolls-Royce plc, for continued use of the phthalate DEHP, which is used in the manufacturing of aircraft engines. Rolls-Royce demonstrated that all risks to the health of workers arising from the use are adequately controlled and that no alternatives for the specific use are available at present. The company will continue to search for suitable alternatives. The total quantity of DEHP used is considerably less than 1 tonne per annum and the substance is ultimately destroyed by the very high temperature in the production process, so that the substance is not present in the final engine. The authorisation will be reviewed by 21 February 2022.
Essential Oils and REACH: Commission and industry meet to address registration issues
A workshop held at the European Commission in Brussels on 8 April brought together representatives of essential oils producers from Member States such as France, Italy and Bulgaria, following serious concerns expressed by the industry that the EU chemicals legislation REACH and CLP (Classification, Labelling and Packaging) would hamper the continuation of their business.
The industry representatives made it clear to the Commission that they are willing to comply and to take up their responsibility, but that their substances are not standard chemicals – their properties and composition may depend on many different conditions. In addition, many producers are small companies that will now face complex chemicals legislation for the first time.
The Commission and ECHA welcomed the industry's commitment to comply, and promised to work together with the sector on the development of specific guidelines for the essential oils industry to help companies fulfil their obligations. At the same time, the Commission is also addressing the concerns expressed by SMEs at a workshop in December last year, at which some essential oils producers were present as well, and will propose implementing legislation to address issues like cost sharing and data sharing in the substance information exchange forums which are a typical requirement of REACH.
REACH aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. REACH also promotes the free circulation of substances on the internal market and aims to enhance competitiveness and innovation. The CLP Regulation ensures that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through classification and labelling of chemicals.