04/2015 - CHINA: odour testing on children's footwear
In November 2013 the CEC informed about new safety technical specifications for children’s and infant’s footwear introduced in China, and requested the contibutions of CEC Members to reply to the WTO notification. The English translation of the draft legislation is available here.
The European Commission with the assistance of our technological centres (FR, IT and ES) sent a reply to the Chinese authorities in December 2013, and asked them for further clarifications. The final documents of the EU comments is available here.
It seems that the European Commission has had various exchanges with the Chinese counterpart on this issue and in particular with regards to questions regarding the odour testing on footwear, as the notified draft sets up five categories of odour ratings for new children footwear and the corresponding testing requirements. The latest reply of the Chinese authorities in available here.
The EU considers that the odour ratings set up in the notified draft, seem to go beyond health and safety concerns and bear many aspects related to the quality of the product. The EU states that odour de facto is per se not harmful or necessarily indication of risks to human safety and environment as perfectly safe materials can emit a strong odour (e.g. rubber and soap) and very dangerous materials may generate no odour at all. The EU considers that the testing procedure for unpleasant odours based on the olfactory sense is not an accurate or precise enough practice for measuring the shoe's potential risks for humans or for the environment.
ACTION REQUESTED TO CEC MEMBERS
The CEC requested CEC Members to provide views, from their technological centers, on the latest reply received from the Chinese authorities before Thursday 16th April 2015 at 13h.
02/2015 - REACH: Risk Management Option Analysis on di-isocyanates
CEC attended a working group on “REACH- Risk Management Option Analysis on di-isocyanates” composed by different European industrial associations. The group is led by ISOPA (European Diisocyanate and Polyol Producers Association) and ALIPA (European Aliphatic Isocyanate Producers Association). The working group is also called PU (Product Stewardship for a sustainable Future) Exchange Panel (previously Board).
The group was created following the decision of the German Competent Authorities (BAuA) to introduce the di-isocyanates (less than 0,1%) in the REACH candidature list of substances of very high concern via the Public Activities Coordination Tool (PACT), under which they have developed a Risk Management Option Analysis .
Early in 2014 the Industry was invited for the first bi-lateral discussions with BAuA in Germany on the approach towards a Use Restriction Dossier on a joint path forward. In May 2014: ISOPA & ALIPA decided on a joint project of both associations and began to liaise with the Downstream Associations for efficient facilitation of the cross value chain activities.
The restriction will affect all companies handling di-isocyanates (TDI/ MDI/ HDI are the 3 DIFFERENT more relevant molecules OF DIISOCYNATES). Within the footwear sector di-isocyanates can be found in thermoplastic polyurethanes, which are used to produce different footwear components (toe puffs, counters and soles), as well as in some adhesives.
N.B. The restriction is only on the use not on the content, therefore soles manufactured outside EU not covered by this restriction.
The conclusions of the Risk Management Option Analysis state:
“The envisaged restriction would prohibit the use of substances, which contains more than 0.1wt% of free di-isocyanate (of whatever kind), unless a company can prove convincingly that they have an internal system in place that ensures that the procedures to handle di-isocyanates are strictly followed. …. if in the end this option would prove to be not viable, it would still be possible to initiate a SVHC/Authorization procedure instead. “
BAuA would like to introduce a restriction of use and in certain applications, which will require specific training of the workforce exposed to di-isocyanates. However, there will be exemptions of the necessary training if it can be demonstrated the very low repercussion on workers.
As a result, the PU Exchange Panel intends to implement a restriction; not a typical restriction because the Panel does not want to restrict a specific use, but instead to restrict the training to those who are exposed to such substances. In order to accomplish this objective, it is necessary to define which products are IN and OUT, and under which criteria can the products be exempted for the training. It is up to each downstream Industry to define which are the product applications to be exempted from this training. And there will be different training needs in each sector and even for each use.
The PU Panel of sector associations led by ISOPA and ALIPA will continue to work in this dossier in 2 ways:
At political level in the PU Panel;
At technical level on the identification of existing training, adaptation to each specific sector, etc. For that purpose, ALIPA/ ISOPA call for the nomination of one expert per sector.
ACTIONS REQUESTED TO CEC MEMBERS
The PU Exchange Panel requests that each downstream association nominates an expert, who can speak on behalf of that particular industry concerning proposed exemptions, which will have to be supported with the proof that these can be used safely without extended training. This discussion is particularly relevant for those companies that produce/consume pre-polymers that may contain higher levels of free di-isocyanates. Taking in account the lack of resources and expertise in this field in CEC’s secretariat, CEC Members are invited to consider the appointment of an expert who could follow this dossier, and analyze whether our sector could get exempted from training; and if not, what kind of training should be delivered?
CEC’s needs to collect information on any training content that is available in our sector from its Members. For that purpose, find here a matrix that lists the specific areas of interest to BAuA, and will allow to get a complete picture of what exists, and will help with define the scope of and the content required for other training.
N.B. On the matrix there are three tabs of which you are kindly requested to complete the one(s) that are most suitable. It is entirely possible that training content and other information available may have to be discussed with BAuA directly by each representative of a sector. It seems that there is already legislation restricting the use of dis-cyanates in Switzerland and Denmark. Furthermore in DK, employees receive a two-day training course before starting the specific position.
But before going into training needs, we should evaluate how many di-isocyanates are there in our footwear industry:
Considering that the dis-isocyanate is in the soles made up of polyurethane, how many soles of polyurethane are manufactured in EU28? How many are there per EU Member State? If we had such information, we could evaluate the impact, and try to avoid to be obliged to develop a specific training course, and even better get the exemption to the training. I have had some initial discussions from our Spanish technological center, INESCOP, and they do not know, but they point out that the TPU (polyurethane thermoplastic) is the material most lately used in the manufacturing of soles, and soles manufacturers buy the material already compressed where there should not be any “free di-isocyanates. However they indicate that there are probably free dis-isocyanates in the “reactive polyurethane”, what is called ISO.
What is the concentration of the di-isocyanates in the process of manufacturing the sole? Again if we had such information and it was lower than 0,1%, we could try to get the exemption from training
Are there any dis-isocyanates in the adhesives used to glue footwear components? If so, in what quantity?
Apparently there are dis-isocyanates in the crosslinking that you add on a 5% in the adhesives for bonding the upper onto the sole. There might be other processes and/or materials used in footwear companies, that include dis-isocyanates, in this case please let us know.
As a sum-up: if training becomes mandatory, as it seems it will, all companies manufacturing soles on PUR and all footwear manufacturers using crosslinking would need to be trained.
European Footwear Ecolabel
The European Ecolabel is a scheme designed to promote products that have low environmental impact during their production, are free from harmful chemicals and are durable. It is intended as a tool to enable consumers to make informed choices about the environmental performance of the products on the market.
The ecological footwear criteria were published in 2002 for the first time and a revision of them was supposed to be in 2006 but the deadlines were extended with the agreement of the ad-hoc working group. Thus the revision took place in 2009 and the new criteria were adopted in July 2009 and were initially valid until 10th July 2013.
However a Commission Decision of 17th June 2013 has prolonged for another two years the validity of the ecological criteria. Article 3 of the Decision indicates that “The ecological criteria for the product group ‘footwear’, as well as the related assessment and verification requirements, shall be valid until 30 June 2015”.
The criteria 2009/563/EC are following closely the format of the 2002 criteria, and they include:
- Requirements to limit toxic residues in the materials and emissions during production, and
- Promotion of durability as an environmental benefit.
Some challenging requirements changes have been added in order to reflect the industry best practices and take into account the improvements available in analytical measurement techniques for harmful substances. Particularly:
- The requirement for hexavalent chromium in leather has dropped in the new criteria from 10ppm to 3ppm, reflecting the introduction of the test method EN ISO 17075, which has a better detection limit in the colourimetric determination of chromium VI;
- For textile materials, the allowable levels of formaldehyde has been reduced to “none detected” (<20ppm) but, for leather, it is still maintained at 150ppm;
- A new criteria for leather limits the amount of water used during tanning processes:
- For hides, the value is 35m3/tonnes;
- For skins is 55m3/tonnes.
Moreover the chromium content of the tannery waste water should not exceed 1mg/l of trivalent chromium – a reduction from a value of 5mg/l in the 2002 criteria;
- The presence of harmful chemicals should be assessed in the final product;
- The requirement for PCP (pentachlorophenol) content has dropped for leather to 0.1ppm – a 50-fold decrease from the 2002 value of 5ppm;
- New requirements have been added to take account of restrictions for chemicals that have been of concern such as harmful dyestuffs, alkylphenol ethoxylates, PFOS, phthalates and biocides;
- Where cardboard boxes are used as packaging for footwear, these should be made from 100% recycled cardboard, this has increased from 80 per cent in the 2002 criteria;
- The durability criteria have undergone very little real change, except for the removal of specific requirements for water resistance for specialist cold weather footwear;
- Where requirements are based on specific components, this would only have to be demonstrated where the individual component makes up more than 3 per cent of the entire shoe by weight. For instance, a decorative trim on the outside of a training shoe would not need to be assessed, as it may only weigh a few grammes, whereas the shoe in total could weigh several hundred grammes;
- For assessment purposes, a functional unit is considered a pair of shoes of size 40 Paris points or 32 Paris points for children’s footwear;
- While environmental management schemes are positively looked on within the Eco-labelling scheme, it is not essential for applicants to have one in order to apply for the label. However, companies that are ISO14001 accredited can receive reductions in the royalty payments for Eco-labelled products.
How to apply for the Eco-label?
- Send a technical dossier that contains all the details of how the product meets the new criteria to an Eco-labelling competent body, there is one in each Member States, and pay a one-off fee, approximately €300-€1,300;
- The competent body of the correspondent Member State will assess the dossier against the criteria and decide if the product meets the requirements. These bodies can ask for more information or require additional testing if the dossier is not complete;
- If the product is accepted for the European Eco-label, a royalty is paid on the sales of the product in the European Economic Area, currently set at 0.15 per cent, with a minimum annual payment of €500 and a maximum of €25,000. These values are based on the product grouping, and not individual styles.
- The revision of the EU Ecolabel criteria will start in October 2013, and the CEC will participate in this process. The new criteria will be based on the requirements described in the EU Ecolabel Regulation 66/2010 on an Ecolabel award scheme. The revision process will consider possible enlargement of the product group scope and definition for leather products other than footwear.
The new criteria will be defined on the basis of the environmental information derived from Life Cycle Assessment and product oriented environmental performance assessment studies. Several environmental, safety, technical and functional aspects will also be considered.
- Interested stakeholders in participating in the revision process can apply by completing the attached registration here and sending it electronically to: JRC-IPTS-FOOTWEAR@ec.europa.eu
Participants will be regularly informed about the progress of the study, will have access to preliminary results and draft documents and will be invited to respond to questionnaires and/or participate at stakeholder meetings.
European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH)
The European Regulation on Registration, Evaluation, Authorization and Restriction of Chemical substances EC 1907/2006 was originally published in December 2006 and has replaced a number of European directives on management and use of chemicals. The adoption of the regulation was not limited to the EU but it was also taken up by the three countries outside the EU: Iceland, Liechtenstein and Norway that together with the EU Member States form the European Economic Area.
The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances and to enhance innovation and competitiveness of the EU chemicals industry. The REACH Regulation lays down restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles.
The Regulation fundamentally changed the way that chemicals were regulated in the region and chemical manufacturers and importers had to demonstrate to the regulators that the substances they supplied did not pose unacceptable risk to human health or the environment. In REACH there are four major categories of roles for organizations, and each organization could recognize itself in more than one; according to the category there are different actions to take:
- Chemical Manufacturer or importer: Any company manufacturing chemicals in Europe (which are prepared from raw ingredients, whether mineral or organic), or importing chemicals into Europe, will need to register each chemical it manufactures or imports. For the purpose of REACH and importer of a chemical has the same obligation as that of a manufacturer;
- Supplier of preparations: In the case of a preparation, each individual chemical present should be registered separately. Example of preparations could include waterproofing spray, cleaners and leather polishes. Any substance that is supplied in quantities of 1 tonne per annum or greater by a single company will require registration, if present as an individual chemical or as a part of a preparation;
- Downstream users: chemicals and preparations can be used to make products. During this process, the workers in factories that use these are referred as to “downstream users”. REACH requires detailed information on the exposure of downstream users to be available as part of the registration process. Therefore chemicals suppliers need to understand how their products are being used by their industrial consumers in order to form them to supply relevant and accurate information;
- Suppliers of articles: This category is for companies that are producing physical products or materials in the EU, or importing them into the EU. It includes footwear and other consumer goods, as well as tanned leathers, finished textile clothes and components. There is no need to register, but there are two distinct sets of requirements that apply to substances in articles. In REACH, these are covered by Annex XVII (mandatory restrictions) and Annex XIV (Substances of very high concern).
Moreover the Regulation established a European Chemicals Agency (ECHA) in Helsinki that acts as the central point in the REACH system and the main tasks are to:
- Help companies to comply with the legislation and provide information;
- Address chemicals of concern and co-ordinate the in-depth evaluation of suspicious chemicals;
- Create a public database in which consumers and professionals can find hazard information.
Polycyclic Aromatic Hydrocarbons (PAHs)
The Commission plans to adopt in the second half of 2013 a Regulation to restrict the concentration of polycyclic aromatic hydrocarbons (PAHs) in consumer products including toys, clothing, shoes, gloves, sportswear, sports equipment and household appliances, etc.
The expected Regulation will amend Annex XVII to the REACH Regulation 1907/2006/EC in order to prohibit the supply to the general public of articles, if any of their rubber or plastic components that come into direct and prolonged contact with the human skin or the oral cavity, under normal or reasonably foreseeable conditions of use, contain more than 1 mg/kg of any of the PAHs. Certain compounds are considered category 1 and 2 carcinogens.