REACH and alternatives to animal testing: new rules for skin sensitisation and skin corrosion/irritation tests
The European Commission will amend 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 new rules will soon become applicable (after publication in the Official Journal, expected for May and September 2016 respectively).
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.
For more information:
The European Commission has opened a 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). Deadline: 22/03/2016. More information...
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.