There is universal agreement among experts and policy makers that the lack of data on human exposure to chemicals represents a major bottleneck in the risk assessment process.
Attempts to conduct risk assessments on chemicals present in consumer products such as toys, textiles, equipment, are confronted by the lack of precise information on the exposure of humans to the chemicals being released (intentionally or unintentionally).
The considerable progress made in assessing exposure to chemicals in products such as cosmetics and detergents is of little value in this context, due to:
- differences in the nature of the products (products are solids, chemicals are mostly liquids or gases),
- patterns of use,
- exposure routes, and
- degree of exposure.
However, even moderate estimates by experts indicate that chemicals present in all types of consumer products are the main source in total human exposure to chemicals.
The EIS-CHEMRISKS project
In order to improve the data on exposure to chemicals, DG Sanco has launched a project with the European Commission's Joint Research Centre:
EIS-CHEMRISKS (The European Information System on 'Risks from chemicals released from consumer products or articles'.)
Building knowledge in this area and developing an EU-wide infrastructure for collecting and disseminating such data is essential to improving risk assessment, and will support the RAPEX notifications under the General Product Safety Directive (GPSD).
EIS-CHEMRISKS is based on a network of national focal points for exchanging the data required. The activities outlined in the EIS-CHEMRISKS Action Plan focus on:
- drawing up inventories,
- harmonising national data sources and exposure assessment models,
- setting up information exchange procedures for identifying and assessing emerging issues,
- developing a European database on human exposure factors, and assessing state-of-the-art approaches to exposure assessment.
This work supports the rapid exchange (RAPEX) notifications system of the General Product Safety Directive (GPSD) and may provide technical support for the relevant aspects of REACH (Registration, Evaluation and Authorisation of Chemicals), regarding downstream users.
For more information, please refer to: REACH legislation (Regulation 2006/1907/EC)
Annual European status reports on ‘Human Exposure to Chemicals' will present the key results of EIS-CHEMRISKS activities (see 'Key Documents' on the European Commission’s Joint Research Centre website).
The one-day seminar for approx. 120 experts took place in Brussels on 29 September 2006.
The main objectives of the seminar were:
- to highlight the most relevant issues of the assessment of consumer exposure to chemicals in products as a crucial aspect of risk assessment;
- to review the need for more effective approaches in this area, in particular in relation to product safety legislation and of the forthcoming REACH legislation on chemical substances;
- to introduce the results of a project conducted by the JRC in order to develop a tool to assist exposure assessment, the European Information System EIS-ChemRisks, and discuss its potential as the basis for a standard framework for consumer exposure modelling and assessment.
Final program . Updated 09-10-2006
Speakers’ presentations - MORNING SESSION
- Bo Oscar Jansson: Setting the scene: Assessment of consumer exposure to chemicals in products and articles: issues, challenges and needs
- Carlos Rodriguez: Detergent/cleaning industry perspective: Risk Assessment of chemicals in detergents and cleaning products, present practices and needs of Industry
- Edmund Vankann: Textile floor coverings - industry perspective: Risk assessment of chemicals in textile floor coverings, present practices and needs of the industry
- Lea Frimann Hansen: Member State experience in the exposure assessment of chemicals in consumer products
- Lesley Onyon: International developments: activities of the International Programme for Chemical Safety (IPCS) for the harmonisation of risk and exposure assessment
- Michael Babich: Consumer exposure assessment: requirements, practices and developments in the US
Speakers’ presentations - AFTERNOON SESSION
- Otto Linher & Björn Hansen: REACH requirements related to consumer exposure
- Demosthenes Papameletiou: The European Information System – EIS-ChemRisks and ChemTest projects
- Gerhard Heinemeyer: Member State Experiences with the EIS-ChemRisks Toolbox
Following the large scale toy recalls during the summer of 2007, the Commission carried out a thorough screening of the EU product safety system.
This screening included an evaluation of the safety measures put in place by businesses in the toy supply chain. In June 2008, the results of this effort were presented with the publication of a report by independent experts entitled " Evaluating Business Safety Measures in the Toy Supply Chain "
The main conclusion of the research was that product safety cannot be guaranteed by final product testing alone but that it has to be a key part of the "quality culture" of an organisation and needs to be embedded in the entire product supply chain. The research also found that it is the smaller players in the market, such as small European importers and traders and small Chinese manufacturers that tend to be the weak link in the product safety chain. A second area where weaknesses have been detected is in relation to the expertise available within Member States' enforcement practices and the role of testing laboratories. The report sets out a series of practical recommendations addressed to each of the stakeholders in the supply chain to strengthen safety controls.
Partnerships with the private sector
To engage the toy sector more actively in the implementation of the relevant recommendations, Consumer Commissioner Kuneva agreed on a voluntary agreement with the European toy industry, in which the industry embarked on a common mission to spread best safety practices through the sharing of expertise, education and training, and closer cooperation with national authorities.
In December 2008, the Commission signed a similar agreement with toy importers and retailers to further improve the safety of toys on the European market. An important part of this agreement consists of the development of clear safety guidelines to outline the systems and procedures that can be put in place to ensure that products meet the required standards, thereby aiming to help especially the smaller actors in the market.
For further information about toy safety and the applicable legislation please see: http://ec.europa.eu/enterprise/sectors/toys/index_en.htm
The biocide dimethylfumarate (DMF) caused severe allergic reactions, including skin itching, irritation, redness, burns and, in some cases, acute respiratory difficulties, in hundreds of consumers in the EU because of its use in imported everyday consumer products such as couches and shoes. There was even one case of a soft toy for small children.
On 1 May 2009, Commission Decision 2009/251/EC came into force in the Member States to ensure that no consumer product containing the strongly sensitising DMF is placed on the market in the EU. If already on the market, these products had to be withdrawn from the market and recalled from consumers without delay, and consumers had to be informed about the serious risk. The Commission Decision was an EU-wide emergency measure, extendable annually (Article 13 of the GPSD), pending the adoption of a more permanent regulatory solution.
On 26 January 2012, Decision 2012/48/EU amended the Decision 2009/251/EC for the third time, extending its validity for a further year, until 15 March 2013. However, a permanent restriction on DMF in articles was developed under Regulation 1907/2006 (REACH), and included in REACH Annex XVII on 15 May 2012. Decision 2009/251/EC then ceased to exist.
Analysis of DMF in consumer products
In order to exchange experiences on the analysis of DMF in consumer products the Commission organised a meeting with Member State experts on 16 June 2009. Experts presented a range of analytical methods which were able to enforce the ban of DMF in consumer products (maximum limit: 0.1 mg/kg).
- Dimethylfumarata and RAPEX notifications - The Commission representative
- Determination of dimethylfumarate - Kaija Luomanperä, VTT Technical Research Centre of Finland
- Test method for dimethylfumarate - Kerstin Scharrer and Pascal Mandin, Intertek
- Analysis of dimethylfumarate in consumer goods - Roberto Battaglia, CATAS
- Analysis of dimethylfumarate - Cécile Retho, Laboratoire d'Ile de France - Massy
- Determination of dimethylfumarate from such as leather or textile method - Jiri Pavlosek, Health Institute Hradec Kralove (Czech Republic)
- Dimethylfumarate - Julia Gonzalez, Instituto Nacional del Consumo (Spain)
- Dimethylfumarate - Patrizia Stefanelli, Italy
Personal music players
Up to 10 million people in the EU risk permanent hearing loss as a result of listening to music at high volume settings over a sustained period. Young people are a particular concern.
That is the conclusion of the EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR).
Decision 2009/490/EC defines the safety requirements for personal music players with respect to the risk of hearing damage by:
- Limit exposure to high sound levels to avoid hearing damage;
- Warnings and information on the risks of hearing damage for users.
The European Committee for Electro-technical Standardisation (CENELEC) drew up new technical safety standards at the request of the Commission.
The references of the standards (EN 60065:2002/A12:2011 and EN 60950-1:2006/A12:2011) are published under:
- the General Product Safety Directive (2001/95/EC);
- the Radio & Telecommunications Terminal Equipment Directive (1999/5/EC);
- the Low Voltage Directive (2006/95/EC).
- Based on a sound limit of 85 dB considered safe under normal conditions of use.
- The user can choose to override the limit so that the sound level can be increased up to maximum 100 dB.
- If the user overrides the limit, warnings about the risks must be repeated every 20 hours of listening time.
- Transition period ends on 24 January 2013. After this date, industry is expected to apply the standards to their products.
- Standards are voluntary. However, conforming products benefit from a presumption of conformity to the safety requirements of the applicable EU legislation on the risk of hearing damage.
- CENELEC will now develop "smart" methods for protection against excessive sound levels based on the measurement of sound dose.
International, multilateral call for immediate action for safety of window blind cords
For the first time three regulators looking after the safety of consumers across the Atlantic (in the EU, Canada and the United States) have joined together to demand strong worldwide safety standards on a specific product. The European Commission’s Health and Consumers Directorate General, the U.S. Consumer Product Safety Commission (CPSC), and Health Canada, have issued a call for better standards on window blind cords. The aim is to reduce the risk of death and injury that corded window coverings present to children.
Photo of a model of blinds
involved in fatalities
Photo showing an example
of a loop in the cords
- This loop is the
For further information on the work of international partners on this issue:
- in the U.S. by the Consumer Product Safety Commission (CPSC) see www.cpsc.gov and www.cpsc.gov/cpscpub/prerel/prereljun10.html
- in Canada by Health Canada, see www.healthcanada.gc.ca/media