INTRODUCTION
The technological development of humanity during the XX and XXI century can not be compared to any other historical period. In the European Union over one hundred thousand substances are commercialized and new molecules are being synthetized continually. “Chemistry” is responsible for these advancements, new cleaning products, paints, etc., 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 innumerable advantages. However, concerns on the lack of information on the effects of numerous substances and mixtures on human health and the environment exist.
Often the prohibitions or restrictions are not being applied until the risks / 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 or DDT if used under excess leading to disorders in the reproduction of birds. 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.
The last two decades of the XXth century and particularly the second half of the 90s huge advancements can be observed in scientific disciplines such as toxicology, ecotoxicology and environmental chemistry, and specially 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-nineties the health and environmental risks of substances that are going to be commercialized in Europe are evaluated and only those that pass the evaluation are authorized. Additionally, some commercialized substances have also been evaluated.
A new challenge has been formulated with 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 and concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The regulation was published December 2006 and came into force in June 2007. However, since then it has undergone many changes and rectifications, mainly in the inclusion and modification of the substances in the annex. The ECHA, 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 modernize the European legislations on chemicals with the aim of improving human health and the environment whilst 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 the 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 the human health or environment.
The main objective of REACH is to balance the responsibility and the competitiveness to the environment and health. That means, promoting sustainable development.
DEFINITIONS
Prior to mentioning the responsibilities of the different parts involved in the 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. Examples: cadmium, phthalates, pentachlorophenol, etc.
MIXTURES OR PREPARATION: Means a mixture or solution composed of two or more substances. Example: Paint, adhesive, detergent, etc.
PRODUCT OR ARTICLE: 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. Example: Footwear, clothes, toys, etc.
DISTRIBUTOR: means 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.
MANUFACTURER: means any natural or legal person established within the Community who manufactures a substance within the Community.
IMPORTER: means any natural or legal person established within the Community who is responsible for import. .
CMR: Carcinogenic, mutagenic or toxic to reproduction.
PBT: Very Persistent and very Bio-accumulative..
vPvB: Very Persistent and very Bio-accumulative.
SDS: Safety Data Sheets.
IMPLICATIONS IN THE SUPPLY CHAINS
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 ton per year or above, must file an application for registration to ECHA. Articles with substances that are to be released in quantities of ≥1 ton / year also must be registered. Up to the present date, the calendar has completed registration for substances that produce > 100 ton 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 was always 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.
Fort the compliance of REACH the communication between footwear manufacturers and manufacturers of intermediate articles is essential. Information shall 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.
REGULATION PROCESS
ECHA is responsible of 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, justification of the confidential information, etc.
The documentation required for the registration varies according to the type of substance and the tonnage, for example:
• If a quantity of ≥10 ton / 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 characterization of the risk has to be added.
The evaluation of the substance registration dossier is analyzed by ECHA, as well as the testing proposals according to the substance and the level of health risk. The agency has the right of analyzing the technical experiments, verify the requirements and communicate with all the member states to obtain the information needed on the substance.
The ECHA is responsible for the authorization 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 level of concern are subject to authorization. These substances shall be progressively added to Annex XIV. Each six months ECHA updates the list of candidates. Up to the present date 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 shall 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 weather 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 can not be placed in the market after the deadline, unless the agency has authorized 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 including new substances restricted or prohibited in order to securing human health and the environment. The substances of Annex XVI subject to authorization may end up on the list XVII as prohibited or restricted.
DESCRIPTION OF THE RESTRICTED SUBSTANCES IN FOOTWEAR AND ITS LIMITS
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, storing or transport.
Substances that can affect the components of footwear are:
• Phthalates: plasticizers 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 fibers 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 should not exceed the amount of 30mg/kg.
•Allergenic and carcinogenic dyes: free of these substances.
•Organotin compounds: Plastic stabilizers 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: 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, however 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 jewelry items) Pb (not detectable in substances and mixtures). For Cr VI in leathers it should not be over 3 mg/kg (ppm).
•Formaldehyde: 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 1500 mg / kg in countries such as Austria and Germany and the substance has to be mentioned in the labeling. Restrictive regulations <75 mg / kg for adults and 20 mg / kg for babies.
•Perfluorinated compounds: 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).
•Ethoxylated alkylphenol: NPEs (nonylphenol) and NPEOs (Nonylphenol ethoxylate). They can be found in flame retardants in textiles, leather and other polymers. The limits are <1000 mg / kg for each one.
•Polycyclic aromatic hydrocarbons: PAHS, organic molecules produced by incomplete combustions. They are in rubber, plastics, dyes. The limits are 1 mg / kg (rubber or plastic items that may be in contact with the skin) and 0.5 mg / kg for baby items.
•Organochlorines (COCs) Trichlorobenzene: are used in the dyeing processes and to dissolve fats, oils and adhesives. It can be found in synthetic fibers such as polyester to improve the absorption and diffusion of the dye into the fiber. Limit <1000 mg / kg.
•Flame retardants: If the sample has been treated with flame retardants or claims to have these characteristics. Usually textiles, PVC, PU or rubber. The limits are 1000 mg / kg of OctaBDE, 10 mg / kg of PentaBDE. As well as exempt of TRIS, TEPA and PBB.
OTHER RELATED REGULATIONS
REACH is a European regulation, however, there exist also 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. If you wish to have more information, you can contact the Department of Environment from the CTCR via phone +34 941 385 870 or by sending an email to This email address is being protected from spambots. You need JavaScript enabled to view it.
BIBLIOGRAPHY
• Fernández García, R., (2007) Reach. España, Editorial Club Universitario
• Supply Chain Toolkit for the textile & footwear industry. SGS
• http://echa.europa.eu/es/
Author: Marta Calvo. Director of Quality at the CTCR.
Contact the QUALITY-LABORATORIES DEPARTMENT
