REACHing the Limit
Published: 07th Sep 2016
In workplaces globally, protective safety footwear is worn to safeguard employees from industrial hazards. Uneven and slippery surfaces, and the risk of items being dropped on the feet and toes causing cut and crush injuries can all be mitigated with the correct footwear.
While it keeps us safe, those manufacturing industrial footwear are concerned not only with our safety, but with ensuring the chemicals used in production of said footwear do not breach the limits set out in the EU Regulation (EC) No 1907/2006 of the European Parliament concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
The technological development of humanity during the 20th and 21st centuries cannot be compared to any other historical period. In the European Union over 100,000 substances are commercialised and new molecules are being synthetised continually. Chemistry is responsible for these advancements, such as new cleaning products and paints, but mostly these substances come to us indirectly as components of manufactured objects, fireproof protectors, polymers, textile treatments or new materials that provide the market with innumerable advantages. Concerns exist, however, on the lack of information on the effects of numerous substances and mixtures on the environment and the health and safety of workers.
Often the prohibitions or restrictions are not applied until the risks or effects of the substances are discovered epidemiologically, when the substances have already been used in huge quantities and the damage is already done.
Examples of this are:
- Asbestos that causes lung cancer
- Benzene leading to leukemia
- DDT if used under excess, leading to reproductive disorders
Society has the impression that too much time passes by until legislative measures show results. Often no cause-effect correlation of some substances is made in relation with the increase of cancer or allergies.
In the last two decades of the 20th century and particularly the second half of the 1990s, huge advancements can be observed in scientific disciplines such as toxicology, ecotoxicology and environmental chemistry, and specifically our capacity to predict on a sound scientific basis the risks of use and production of chemicals.
Since the protection of health and the environment are fundamental principles to the European Union, governments try to incorporate the possibilities offered through the advancements of science into the regulatory framework. Since the mid 1990s the health and environmental risks of substances that are going to be commercialised in Europe are evaluated and only those that pass the evaluation are authorised. Additionally, some commercialised substances have also been evaluated.
A new challenge has been formulated in this new century: “to have scientific sound assessments for all substances that are being produced or imported.”
This objective is being implemented through the EU Regulation (EC) No 1907/2006 of the European Parliament concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The regulation was published December 2006 and came into force in June 2007. Since then, however, it has undergone many changes and rectifications, mainly in the inclusion and modification of the substances in the annex. ECHA, the European Chemicals Agency, was also established and is responsible for managing the technical, scientific and administrative aspects of the regulation. Through this regulation, the European Union has sought to modernise the European legislations on chemicals with the aim of improving human health and the environment, while maintaining the competitiveness and strengthening innovation in the European chemical industry.
The legislation ensures that all companies that want to produce or import and use chemicals in the EU must prove the safeness of the substance, that means fulfilling the obligation of registry. Additionally, and for the first time, both chemical producers and importers have responsibility for the damages that the product might cause and have to register the substance. They have to guarantee that they manufacture, import and use substances that do not affect negatively human health or the environment.
The main objective of REACH is to balance the responsibility and the competitiveness to the environment and health. That means promoting sustainable development.
Prior to mentioning the responsibilities of the different parts involved in the industrial footwear supply chain, we have to take into account some definitions of the regulation on words such as substance, mixture or preparation, article or product, as well as the agents of the supply chain and others that we need to be aware of in order to understand the strategy of the regulation.
Substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition; for example, cadmium, phthalates, and pentachlorophenol.
Mixtures or preparation
This means a mixture or solution composed of two or more substances; for example, paint, adhesive and detergent.
Product or article
This means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition; for example, industrial footwear and protective clothing.
The distributor is any natural or legal person established within the community, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties.
The manufacturer is natural or legal person established within the community who manufactures a substance within the community.
Any natural or legal person established within the community who is responsible for importing.
- CMR - Carcinogenic, mutagenic or toxic to reproduction
- PBT - Persistent bioaccumulative and toxic
- vPvB - Very persistent and very bio-accumulative
- SDS - Safety data sheets
Implications in the footwear supply chain
The main responsibilities of REACH are for manufacturers and importers, as all manufacturers or importers of substances (in the form of substance or preparation), in quantities of one tonne per year or above, must file an application for registration to ECHA. Articles with substances that are to be released in quantities greater than one tonne per year must also be registered. Up to the present date, the calendar has completed registration for substances that produce more than 100 tonnes a year of substances.
The sector in which we operate, most are downstream users. These use the substances or mixtures subject to regulation within the manufacturing of footwear or components.
Communication is and always was essential for identifying the use of substances in the registration phase. Among preparation manufacturers and suppliers of substances there has always been communication as to whether the substance that is being produced was to be registered and its uses. Moreover, manufacturers of articles should communicate to the providers of preparations the uses of the articles.
For the compliance of REACH the communication between footwear manufacturers and manufacturers of intermediate articles is essential. Information must be requested from the suppliers on the intermediate articles (leather, textiles, flooring, adhesives, ornaments, etc.) if these contain any SVHC (Substance of Very High Concern) in a concentration higher than 0.1%.
In addition, downstream users must communicate in both directions:
- Inform the manufacturers and importers on the uses of substances or mixtures
- Provide the SDS (Safety Data Sheet) to the agents involved in the supply chain
- Keep the SDS and implement the preventive measures
- Inform the customers whether their products contain any of the substances of high concern
ECHA is responsible for coordinating and ensuring the compliance with the REACH regulation, being involved in each of the four regulatory processes.
For the registration of a substance (technical dossier IUCLID 5, International Uniform Chemical Information Database, database for information on chemicals) a series of tasks according to annex VI have to be fulfilled such as: general and specific information, identity of the manufacturer or importer, identity of the substance, information on its manufacturing, information on the exposure, testing proposals, a guide for safe use of the substance, summaries on the information required by annex VII to IX, and justification of the confidential information.
The documentation required for the registration varies according to the type of substance and the tonnage, for example:
- If a quantity of more than 10 tonnes per year is registered, the CSR (Chemical safety report) has to be added, including the risk evaluation and the PBT (Persistent bioaccumulative and toxic) and vPvB (very persistent and very bio-accumulative) evaluation.
- If the substances are dangerous, that is, CMR (carcinogenic, mutagenic or toxic to reproduction), PBT or vPvB, additionally to the safety report an assessment of the exposure for each use and characterisation of the risk has to be added.
The evaluation of the substance registration dossier is analysed by ECHA, as well as the testing proposals according to the substance and the level of health risk. The agency has the right of analysing the technical experiments, verifying the requirements and communicating with all the member states to obtain the information needed on the substance.
The ECHA is responsible for the authorisation of substances, ensuring that the risks of SVHC (Substance of Very High Concern) are properly controlled and that these substances are progressively replaced by suitable alternatives.
CMR category 1 or 2, PBT, vPvB and other substances that generate equivalent levels of concern are subject to authorisation. These substances must be progressively added to Annex XIV. Each six months ECHA updates the list of candidates. At present there are 168 substances. The inclusion of a substance is a clear sign that the substance will in the future be considered unfit to be used and technical alternatives should be found, promoting innovation.
Under following link you can find the list of candidates: http://echa.europa.eu/web/guest/candidate-list-table
If there exist any doubts on whether a substance is in the list or which are its limitations, a search for the substance can be carried out here: http://echa.europa.eu/es/search-for-chemicals
These substances cannot be placed on the market after the deadline, unless the agency has authorised it and no other alternative exists. Given that case, it would have to be reviewed again.
Restriction: Any restriction or prohibition imposed on the manufacturing, use or sale of a not accepted substance for health or the environment, will appear with restrictions in Annex XVII Substances restricted under REACH.
Modifications have been introduced over the years:
- Commission Regulation No 276/2010 amending REACH as regards Annex XVII (dichloromethane, lamp oils and grill lighter fluids and organostannic compounds)
- Commission decision of 20 April 2010 on the re-examination of the restriction concerning short-chain chlorinated paraffins
- The last modification of REACH is 317/2014 to Annex XVII. ECHA will modify this list to include new substances restricted or prohibited in order to secure human health and the environment. The substances of Annex XVI subject to authorisation may end up on the list XVII as prohibited or restricted
Restricted substances in footwear
Generally speaking, prohibited substances can be found in footwear and its components, as they might have been used in the production process, through impurities from other components, or through contamination during conservation, storage or transport.
Substances that can affect the components of industrial footwear follow.
Plasticisers to increase the flexibility in plastic. 2-ethylhexyl phthalate (DEHP), phthalate dibutyl (DBP), butyl benzyl phthalate (BBP), diisobutyl phthalate (DIBP), phthalate di-n-octyl (DNOP), diisononyl phthalate (DINP) and diiodecyl phthalate (DIDP) can be found mainly in PVC and PU, and textile and leather coatings. The sum of all the phthalates should not exceed the limit value of 0.1% of the total weight (1000mg/kg), as footwear is an article that children can put into their mouth.
Chlorinated phenols, polychlorophenols
Substances derived from phenol: pentachlorophenol (PCF-PCP), tetraclorofenol (TeCP-TeCF), triclorofenol (TCP-TCF). Leather conserving substances (leather bactericides), natural fibres conservatives and fungicides in textiles and leathers. They should not exceed 1000mg/kg, more restrictive regulations <0.5mg/kg.
Dimethyl fumarate DMFu
Fungicides and conservative, anti-fungal agents. They can be found in leather and textiles of finished products. DMFu should not exceed 0.1mg/kg.
Azo dyes and arylamines
Azo dyes and arylamines should not exceed the amount of 30mg/kg.
Allergenic and carcinogenic dyes
Free of these substances.
Plastic stabilisers used in biocides and pesticides as catalytic agents. Tributyltin (TBT), dibutyltin (DPT), dicotyltin (DOT), triphenyltin (TPT), tetrabutyltin (TebT), mono-n-octyltin (MOT) and tricyclohexyl tin (TCyT) are in coatings, PU and PVC foams and in textiles. They should not exceed 1000mg/kg.
Heavy metals are those that exceed a density of 4gr/cm3 or its atomic weight is between 63,55 and 200,59. They are: arsenic (As), lead (Pb), cadmium (Cd), nickel (Ni) mercury (Hg) and chromium (Cr).
Arsenic (As) may appear in loads in PVC, in leather conservatives, textiles. Lead (Pb) can appear in inorganic pigments or in PVC and leather finishes. Cadmium (Cd) is often used in textiles and plastics (PVC), dyes and metal accessories. Hexavalent chromium (Cr VI) is often used as an oxidizing agent in leather, plastics and dyes. Nickel (Ni) in buckles, eyelets and mainly metal accessories, as well as plastics, paints, inks. Mercury (Hg) is already excluded from all stages of textile and fashion production, but it can appear as a contaminant in the refining process.
The detection limits are As (not detectable) Cd (100mg/kg), Hg (not detectable), Ni (0,5 µg/cm2 jewellery items) Pb (not detectable in substances and mixtures). For Cr VI in leathers it should not be over
Formaldehyde is a volatile organic compound. Due to its chemical properties, it is used as wrinkle remover in textiles and as a leather tanning agent. The limits are 1500mg/kg in countries such as Austria and Germany and the substance has to be mentioned in the labeling. Restrictive regulations <75mg/kg for adults and 20mg/kg for babies.
PFOS (Perfluorooctanesulfonic acid) and PFOA (Perfluorooctanoic acid). Products used as waterproof and anti-stain finishes in textiles and leather. The limits are <1000 mg / kg for articles or semi-finished products.
Short-chain chlorinated paraffins
(defined in Regulation 519/2012) SCCPs chemical compounds based on chloralkanes (C10-C13) are found in leathers, fatliquors in the post tanning process, plasticizer in rubbers, dyes and adhesives. The limits are <10,000 mg / kg (substances and preparations) and <1500 mg / kg (articles).
NPEs (nonylphenol) and NPEOs (Nonylphenol ethoxylate). They can be found in flame retardants in textiles, leather and other polymers. The limits are <1000mg/kg for each one.
Polycyclic aromatic hydrocarbons
PAHS, organic molecules produced by incomplete combustions. They are in rubber, plastics, dyes. The limits are 1mg/kg (rubber or plastic items that may be in contact with the skin) and 0.5mg/kg for baby items.
Organochlorines (COCs) Trichlorobenzene
Organochlorines (COCs) Trichlorobenzenes are used in the dyeing processes and to dissolve fats, oils and adhesives. It can be found in synthetic fibres such as polyester to improve the absorption and diffusion of the dye into the fibre. Limit <1000mg/kg.
If the sample has been treated with flame retardants or claims to have these characteristics. Usually textiles, PVC, PU or rubber. The limits are 1000mg/kg of OctaBDE, 10mg/kg of PentaBDE. As well as exempt
of TRIS, TEPA and PBB.
Other related regulations
REACH is a European regulation, but there also exist other European and international norms such as Proposition 65 (EEUU), CPSCIA (Consumer Product Safety Improvement Act, Public Law 110-314) (EEUU), Japanese Law 112, Norm GB 18401:2003 and GB 20400:2006 (China), Biocidal Product Regulation (BPR, Regulation (EU) 528/2012), CADS (Germany), etc. These norms set other requirements and have higher and / or different levels of demand from REACH. The Footwear Technology Centre of La Rioja, CTCR, has more information on the applicable requirements of each country and for each hazardous substance that could affect the footwear industry and its components.
By now we’re well versed in the dangers of asbestos, but after how many years? And with how many lives lost? Is it only a matter of time before some of the chemicals currently used in footwear production are discovered to be the new asbestos?