Restricted substances list

A multitude of regulations on chemical substances

“Restricted Substance List”, or its commonly used abbreviation “RSL”, has become a common term in the tanning industry.

It is important to distinguish between a

  • Product Restricted Substance List
    (often called PRSL) which restricts the use of chemicals in the final product (i.e. leather)

and

  • Material Restricted Substance Lists
    (i.e. MRSL issued by ZDHC) which addresses restricted chemicals in the chemical product used for making leather.

The first question that immediately arises is: Who sets the requirements in the RSL lists that are on the desk in the tannery office?

Basically there are 2 groups involved:

1. Legislators

  • National regulations and laws
  • International agreements and regulations

2. Manufacturers/Brands, Ecolabels, NGO’s and consortiums (such as ZDHC)

  • Ecolabels for consumer items
  • Restricted Substance Lists (RSL) for consumer products like leather
  • Restricted Substance Lists for chemical products (i.e. MRSL issued by ZDHC)

National regulations and laws

Each country has its own regulations and laws regarding chemicals. If we look at restricted chemical substances on a global basis, it is clear that some countries have considerably more regulations in this area than others.

REACH

Worldwide the strictest regulations for chemicals are those in the European Union (EU) countries, where all the many previous chemical EU Directives have been put together into one Annex (Annex XVII) of the EU Regulation 1907/2006, commonly called REACH. This regulation is mandatory for all 26 EU countries.

The EU-REACH Regulation
(and the former EU Directives) restricts either:

  • The sale or manufacture within the EU of product formulations containing more than certain amounts of chemical substances

or

  • The presence of certain chemical substances in consumer goods.

What does REACH mean for the European tanner?

The European tanner purchasing a chemical froma European supplier will be required to disclose to the chemical supplier the use of such chemical to ensure that a valid, risk based exposure scenario for the identified use can be established. The REACH registration of a chemical substance and the considerable costs associated with it are the responsibility of the EU chemical manufacturer or importer of the chemical. Only if the tanners are themselves importing chemicals into the EU, they will be directly involved in the registration process.

What does REACH mean forthe non-European tanner?

Tanners in other parts of the world will not need to undertake any registration process but will need to be careful with the selection of their chemical products. If their leather will be exported at some stage to European customers, the leather must comply with REACH restricted substance requirements for consumer items, as given in Annex XVII of the EU Regulation. In addition, the Substances of High Concern (SVHC), as listed in Annex XIV (REACH), must not be present in the leather at more than 0.1 % (= 1000 ppm).

Other countries are planning or have already started to implement similar chemical regulations to the REACH Regulation for the EU countries. The hope is that there will not be significant variations between countries in terms of the legislation. Harmonisation of the requirements would be an advantage to all, but this is not yet the case.

In the USA the Federal Agencies, EPA (Environmental Protection Agency) and CPSC (Consumer Product Safety Commission) control regulations and guidelines at a national level. In addition, the individual states have their own regulations. For example, the state of California has its “Proposition 65” regulation, which protects Californian citizens from exposure to certain harmful substances whose presence has to be listed on consumer items with appropriate warning phrases.

Japan has regulations for harmful substances; the most commonly seen in the leather industry is the Law 112 restricting harmful substances (e.g. formaldehyde) in household products.

China has national standards, for example: GB 18401 and GB 20400, which limit the amount of harmful substances in consumer items.

Regulations in one area can very quickly have an impact on a global basis, this is typical of a number of EU restrictions. Many leather articles made in other parts of the world end up being sold in the EU countries or in countries which exercise similar chemical regulatory practices. A good example is the forbidden aromatic amines fromazo dyes or PCP (Penta Chloro Phenol), where the initial EU Directive quickly became the requirement worldwide.

International agreements and regulations

There are several international treaties and agreements administered by the United Nations which limit specific chemicals. Two examples of these international treaties are:

The “Montreal Protocol on Substances that Deplete the Ozone Layer”, designed to globally phase out the use of substances that can cause a reduction in the ozone layer. The Montreal Protocol has been ratified by 196 nations and requires countries to implement their own legislation. For example, the EU implemented Regulation1005/2009 that lists and controls the use of all the ozone depleting substances in EU countries.

The “Stockholm Convention on Persistent Organic Pollutants (POPs)” is signed by 151 countries. It requires the parties involved to take measures to eliminate or reduce the release of POPs into the environment. Initially 12 POP substances were identified and in May 2009 an additional 9 substances were added. These substances are chlorinated organic pesticides, brominated organic flame retardants and perfluoroctane sulfonates (PFOS).

Eco labels for consumer items

Behind each Ecolabel stands mostly a test institute or a group of test institutes

There are an increasing number of Ecolabels available. To be successful, the Ecolabel needs to be recognised and to be used with consumer items. In most cases, behind each Ecolabel is a test institute or a group of test institutes, who are responsible for monitoring the compliance and issuing of the Ecolabels. In Europe, the promoting, marketing and testing for Ecolabels are now a considerable commercial business for those test houses involved and some brands link their products to an Ecolabel.

  • Ecolabels and brands are usually the first to react to “chemical dangers”, which are published in media reports and by pressure groups
  • Usually the Ecolabels are a head of any legislation on the topic
  • Most have established their own “restricted substance” specifications and these are often mistakenly interpreted by tanners to be official regulations for Europe

Some typical examples of Ecolabels seen in European shops on clothes and leather articlesare: Oeko-Tex 100, SG Label, Blue Angel issued by the German Government for Environment, PFI Label, etc. These labels inform the customer that the consumer article has been tested for harmful substances and is in compliance with the specifications of that particular Ecolabel.

Note:

Many Ecolabels are strongly textile oriented and, for example, restrict the total chromium (Cr) to very low values, which makes it effectively impossible that chrome-tanned leather articles can comply.

EU Footwear Ecolabel

The EU Footwear Ecolabel has been developed to use the “EU flower” Ecolabel for footwear that comply with restricted substances in the shoe and packaging, as well as complying with ecological requirements during the various material and shoe manufacturing operations and during its use. The aims of this Ecolabel are well intended but without a commercial organisation promoting and marketing it, like other successful Ecolabels, it will be difficult to get acceptance by the footwear industry.

EU Footwear label addresses the Environmental impact and life cycle analysis considering:

  • Packaging
  • Emissions while producing material, especially leather tanneries (COD criteria for waste water, Cr recovery, short chain chlorinated paraffins, forbidden chemicals)
  • Energy consumption and product environmental footprint
  • End of life – best use option
  • PVC, nitrosamines in rubber
  • Durability criteria

Manufacturers, brands, NGO’s ZDHC Programme

The MRSL List by ZDHC: The MRSL issued by ZDHC can be seen as an important approach consolidating valuable RSL data into one managebale list of restricted chemicals

Zero Discharge of Hazardous Chemicals

The ZDHC foundation is a collaboration of Green Peace with global signatory brands, value chain affiliates and associates whose goal is the elimination of hazardous chemicals from the textile and footwear supply chain. The ZDHC programme is based on Input Stream Management which means regulating the use of hazardous chemicals right from the beginning of the value chain. ZDHC has established a Material Restricted Subtsance List (MRSL) not only for textile industry but also recently for leather chemicals. The MRSL list gives allowable limits of hazardous substances and the related testing methods for such chemicals. The MRSL is based on data from important national and international regulations and studies but also on the input from brands and manufacturers. The MRSL can be seen as an important approach consolidating valuable RSL data into one managebale list of restricted chemicals. The MRSL list is a living document and currently does not include biocides and substances like formaldehyde which are addressed by individual RSL and regulations.

Global brands

The global brands, some examples are Adidas, Nike, H&M, Clarks, IKEA, etc., publish their ownlists of restricted substances (RSL) and update them at regular intervals. The limit values in the lists are for leather and other materials being used by these global brands. Many tanners supplying the global brands then use or copy these lists and pass them on down the supply chain, for example to their chemical product suppliers, with the same limits and the same test methods. In many cases the test methods are specifically for leather and not suitable for analysing chemicals. In most cases the global brands base their specification limit values on various regulations that already exist. For example, the limit for nonylphenol ethoxylate surfactants (NPEO) in leather is often 1000 mg/kg as in the EU Regulation for chemical formulations but there are brands which set limits as low as 100mg/kg (100ppm).

When a regulation does not exist, the brands establish their own limit values. For formaldehyde in leather, where there is no EU Regulation, the typical limits in leather with skin contact are 20 mg/kg for baby shoes and 75 mg/kg (Japan) / 100mg/kg for adult clothes and shoes. If there is no skin contact, the formaldehyde limits are typically around 300 mg/kg. Interestingly the cosmetic industry allows skin contact items with considerably higher levels for releasable formaldehyde. Often allowable limits in RSL lists are not clearly science or risk based but are a precautionary measure or result from ‘green’ competition.

Automotive industry

The European automotive industry has to comply with the End of Life Vehicle Directive requirements and has set up a data base to record each component used in cars. To ensure that information on restricted substances is collected worldwide, the Global Automotive Declarable Substance List (GADSL) has been established and requires those in the supply chain to provide information for the listed 139 substances. The GADSL list is normally updated each year.

In the recent past an increased emphasis is put on interior car air quality where car seat leather plays an important role with regards to emissions of volatile substances, which are hazardous and of potentially unpleasant odor.

The Japanese Automotive Industry (JAMA) introduced in 2005 voluntary air quality standards which limit the emissions inside cars. This data was taken directly from that for emissions inside houses and corrected for the volume difference; so it also included some household substances that are not found inside a car. More important is that in addition to formaldehyde, for the first time acetaldehyde was restricted – at a very low level.

The GB/T 27630-2011 (Guidelines for Air Quality Assessment of Passenger Vehicles) issued by the Chinese Ministry of Enviornmental Protection goes in a similar direction as JAMA but including further hazardous substances.

Chemical substances of concern in leather manufacture

Global Automotive Declarable Substance List: Despite the fact that RSL product lists contains hundreds of substances only few are of real concern

RSL lists range from small lists with the key substances relevant for leather, to very large lists with many hundreds of different chemical substances of which only a few are of real concern for leather. In the following section the most relevant substances for leather are put together (They are reviewed in more detail in section Restricted Substances)

Legally restricted chemical substances

The following chemical substances are restricted through legal restrictions:

  • Allergenic and sensitising dyes
  • Aromatic amines from azo dyes
  • Boron containing substances
  • Brominated organic flame retardants
  • Chlorinated paraffins (short chain, C10 – C 13, SCCP)
  • Chlorinated phenols (PCP, TeCP and TriCP)
  • Chromium (VI)
  • Dimethyl fumarate
  • Heavy metals
  • N-methyl pyrrolidone
  • Nonylphenol ethoxylate and nonylphenol
  • Organotin compounds
  • Perfluorooctane sulfonate (PFOS and related PFOA)
  • Phthalates
  • Polyaromatic hydrocarbons (PAH)
  • Substances of Very High Concern (SVHC)

Chemical substances restricted by Ecolabels, brands and manufacturers

The following chemical substances can be restricted by Ecolabels and brands:

  • Formaldehyde
  • Acetaldehyde (air emission)
  • Biocides
  • Hazardous volatile organic substances (VOC)

How to comply with the various RSL?

Input stream management

It is a problem for tanners to find their way through the jungle of regulations and customer requirements for restricted substances. Many substances in the long lists have no relevance for the leather industry; take the example of a tanner requesting a written statement that there is no asbestos fibres in the leather chemicals he is using. Harmonisation of the large numbers of restricted substance lists would be a very positive thing for all concerned, but considering the various interest of all stakeholders it is not easy to achieve in today’s environment. The most promising approach however in this direction is the Material Restricted Substance List for chemical products used for leather manufacture. It list all chemical substances which should not bepresent in a chemical product beyond a given limit. The MRSL is issued by ZDHC a multi stakeholder association where NGO, brands and chemical manufacturers (via the LWG-Leather Working Group) and other experts working together. The MRSL list is being updated continuously and represents state-of-the-art knowledge on restricted substances. It is an approach which is based on Input Stream Management which means avoiding restricted substances right from the beginning of leather manufacture.

Not included in the MRSL list are biocides and products like formaldehyde, acetaldehyde and chromium (VI) which need to be addressed individually and be tested for. Apart from these the ZDHC-MRSL list is likely to cover the rest of the RSL requirements from brands and manufacturers. TFL uses the ZDHC–MRSL requirements as a base for their RSL management policy which also takes into account other legal requirements.

TFL Product Compliance Policy

1. Regulatory compliance

The chemicals of TFL listed in Annex A of this declaration:

  • Comply with the European Union (EU) regulations 1907/2006 (REACH) and 1272/2008 (CLP Regulation). As required by these EU Regulations, TFL identifies hazards in Section 2 of the respective Safety Data Sheet (SDS) and lists substances classified as hazardous to health or the environment clearly in Section 3 of the respective SDS. The SDS is the legally prescribed document regarding safety of individual chemical products supplied.
  • Comply with the REACH requirements for Substances of Very High Concern (SVHC) in REACH Annex XIV (authorisation) and in the Candidate List for SVHC (according to art. 59.1 of REACH). TFL products listed in Annex A are in compliance with the SVHC and SVHC candidate list, including its concentration limit requirements. The SVHC candidate substance list is updatedevery 6 months and available at: http://echa.europa.eu/candidate-list-table
  • Comply with the restricted substance requirements of REACH Annex XVII REACH Annex XVII contains the EU restrictions for the manufacture, marketing and use of chemical substances, and is available at: http://echa.europa.eu/addressingchemicals- of-concern/restrictions/substances- restricted-under-reach
  • Comply with EU Biocide Regulation528/2012TFL leather chemicals comply with EU regulation 528/2012 concerning the sale and use of biocidal products. The text of the regulation is available at: https://echa.europa.eu/regulations/biocidal- products-regulation/legislation

2. Compliance with the requirements of the Manufacturing Restricted Substances List (MRSL) of ZDHC (Version 1.1, December 2015)

TFL has issued a separate Product Compliance Statement which is updated regularly and which applies to all TFL products. In a special Annex it also lists the (trace) level amounts of formaldehyde, phenol and metals contained in some TFL products. It also lists biocide actives TFL is using and which all comply with EU Biocide Product Directive (BPD). Such a Product Complaince Statementis a living document since the substancelists are continually being updated. Many of them derive from REACH where Substances of Very High Concern are identified on a risk and sciencebased analysis and put onto the SVHC list.

Based on practical tests and experience TFL believes that by using their products in a correct way it is possible to make leather which is safe to the consumer and the environment and which satisfies all major RSL requiremenst in the industry.

Verification of a chemical supplier’s conformance

It is the right of a leather manufacturer to know how trustworthy a RSL statement issued by a chemical supplier really is. If he can rely on a chemcials suppliers statement he will be able to eliminate a lot of (unnecessary) testing of his final product and focus on substances which can be formed or reduced during manufacture (e.g. Cr(VI), formaldehyde, acetaldehyde).

In the textile chemical industry audit and certification systems for chemical suppliers already exist (i.e. BlueSign, GOTS, OekoTex Eco Passpart). For the leather chemical industry discussions are on the way to develop something similar. For the time being, however, chemical suppliers are doing self assessments based on internal audits etc.

TFL has established an internal system which consists of own chemical testing and chemical testing of raw material (chemical substance)suppliers. TFL will align with an external audit and certification system as soon as an appropriate one is in place.

It is very clear that chemical substances need proper and meaningful testing while avoiding unnecessary testing. It is important to note that the increasing requirements to ensure chemical safety generate significant costs throughout the supply chain and these will inevitably be reflected in the price of the final product.