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REACh and its Impact on the Leather Sector

On 1 June 2008 REACh entered an operational phase by implementing pre-registration. The aim of this article is to explain the obligations of the various types of company included in the scope of REACh and to suggest the action plans to be set up for each one.

1- WHAT IS REACH?

REACh is a European regulation on managing the marketing of chemical substances. It came into force in June 2007 but includes several phases Schedule until 2020. The sector the most affected by the regulation is the chemicals industry. All manufacturers or importers of over 1 tonne/year of a chemical substance, however dangerous, will have to provide information on its toxicological characteristics. This approach imposed by the REACh regulation comes from the fact that of all the substances currently available on the market in the European Union (approximately 100,000), only a small percentage are in fact really well known (around 4,300).

REACh is a European regulation on managing the marketing of chemical substances. It came into force in June 2007 but includes several phases Schedule until 2020. The sector the most affected by the regulation is the chemicals industry. All manufacturers or importers of over 1 tonne/year of a chemical substance, however dangerous, will have to provide information on its toxicological characteristics. This approach imposed by the REACh regulation comes from the fact that of all the substances currently available on the market in the European Union (approximately 100,000), only a small percentage are in fact really well known (around 4,300).

One of the objectives of REACh is therefore to overcome the lack of knowledge of the effects of chemical substances by studying them in depth. These are the "Registration" and "Evaluation" phases that should apply to around 30,000 of the most used substances. A pre-registration phase between 1 June 2008 and 30 November 2008 will enable the manufacturers or importers in question to declare their intention of registering the substances that concern them with the European CHemical Agency (ECHA) that has been specially set up to manage the implementation of the European Regulation. The pre-registration will offer manufacturers and importers a time-frame for applying for registration from 3, 6 to 9 years depending on the quantities and dangerousness of the substances in question.

One of the major aspects of REACh applies to a category of substances considered to be "of very high concern", for which the regulation has developed a special procedure: “Authorisation”. A substance of very high concern is by definition a substance whose effects on people and the environment are extremely harmful ( carcinogenic, mutagenic, reprotoxic, bioaccumulative). With the implementation of REACh, the European Union wishes the use of this type of substance to be eventually as limited and as controlled as possible. For this type of substance REACh therefore imposes the following procedures:

  • All manufacturers or importers of substances of very high concern listed in Annex XIV of the regulation must obtain marketing authorisation for the substance for clearly defined uses. The authorisation will include an obligation to implement research and development programmes to identify less dangerous substitutes.
  • All manufacturers or importers of “articles” must inform their clients whether the raw materials (leather, textiles, plastic polymers, etc.) or manufactured products they sell contain any substances of very high concern listed in Annex XIV of the regulation at a concentration higher than 0.1 wt % (1g/kg).
  • Any consumer may ask companies that market manufactured products whether the articles in question contain substances of very high concern listed in Annex XIV of the regulation at a concentration higher than 0.1 wt % (1g/kg).

Marketing authorities take this aspect very seriously. The RIP (REACh Implementation Project) guidance document 3.8 (May 2008 version) concerning articles stipulates that these conditions on the supply of information are to be applied when the first "candidate list" of substances of very high concern is published in late 2008-early 2009. Another aspect of the REACh regulation is the setting up of Restrictions. The “administrative” threshold of 0.1 wt % (1 g/kg) that compels companies to provide information on substances does not imply that the current or future limits in force on articles may no longer apply. Take the example of aromatic amines that are regulated in the European Union: the authorised threshold for marketing will remain 30 mg/kg (detection limit) and the European Directive prohibiting aromatic amines is now included in REACh.

If it becomes apparent that a substance may have damaging effects on consumers’ health or the environment at the end of an article’s life, the REACh regulation will therefore impose restrictions with thresholds much lower than 0.1%.

2- WHAT PLAN OF ACTION REGARDING REACH?

The manufacturing industry will have to rule on whether it is forced to provide information on the presence of substances of very high concern in materials or finished, manufactured or imported products. We have defined three business profiles, specified the REACh obligations and described a plan of action for each one.

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PROFILE NO.1: TANNERS AND FELLMONGERS ARE AFFECTED IN TWO ASPECTS:

Profile No. 1: tanners and fellmongers are affected in two aspects:

If you use chemical products:

What does reach impose?
Immediately (pre-registration began on 01/06/2008 and will end on 30/11/2008) inform your suppliers of the uses to which your chemical products are put such that they may be taken into consideration in the registration phase for the tanners/fellmongers sector.

What you must do?
Write to your suppliers asking them whether, for your industrial sector, they intend to register with the European Agency the substances present in the chemical products they supply.

How?
There is no particular method: by letter, e-mail. What is important is to ensure traceability of your requests and their answers. (Model letters are available from CTC.)

If you are an article manufacturer (leather is considered to be an article, as are most raw materials):

  • Determine whether the materials you produce contain substances of very high concern listed in Annex XIV of the regulation at a concentration of > 1g/kg.
  • If so, inform your customers of the fact immediately.
  • Keep any supporting documents that may be used to rule on the 1g/kg threshold for 10 years after the substance in question has stopped being marketed.
  • Identify as quickly as possible the substances of very high concern used in the production process
  • Evaluate their concentration in the substance produced.
  • If you are affected, make the necessary calculations as soon as the Candidate List is published in late 2008/early 2009.
  • Examine the safety data sheets of the chemical products used in the production process to identify substances of very high concern. When the Candidate List is published, check whether it includes the substances you have identified. For each substance concerned you must:

a) estimate the annual consumption of substances of very high concern identified,
b) estimate the annual production of substance produced (weight),
c) estimate the concentration of substances of very high concern identified in the produced substance.

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PROFILE NO.2: IF YOU PERFORM A PRODUCTION ACTIVITY IN THE GLOVE-MAKING, SHOE OR LEATHERWORK SECTORS, THERE ARE AGAIN TWO ASPECTS OF REACH, WHICH EFFECT YOU.

If you use chemical products:

What does reach impose?
Immediately (pre-registration began on 01/06/2008 and will end on 30/11/2008 Inform your suppliers of the uses to which your chemical products are put such that they may be taken into consideration in the registration phase for your sector of activity (glovemaking, shoe or leatherwork, etc.).

What you must do?
Write to your suppliers asking them whether, for your industrial sector, they intend to Register with the European Agency the substances present in the chemical products they supply.

How?
There is no particular method: by letter, e-mail. What is important is to ensure traceability of your requests and their answers. (Model letters are available from CTC.)

If you are an article manufacturer:

What does reach impose?

  • As quickly as possible (The obligation to provide information will begin in late 2008/early 2009 when a Candidate List will be published of substances of very high concern listed in Annex XIV of the regulation.) determine whether the finished products you manufacture contain substances of very high concern listed in Annex XIV of the regulation at a concentration of > 1g/kg.
  • If so, inform your customers of the fact immediately.
  • Keep any supporting documents that may be used to rule on the 1g/kg threshold for 10 years after the substance in question has stopped being marketed.
  • If you market finished products (to the general public) you have 45 days in which to answer any consumer questions regarding the presence in your products of substances of very high concern listed in Annex XIV of the regulation.
What you must do?
  • Determine whether the materials you purchase (EU and outside EU) contain substances of very high concern listed in Annex XIV of the regulation at a concentration of > 1g/kg.
  • Evaluate their concentration in the substance produced.
How?
  • Write to your EU-based suppliers asking them whether the substances you buy from them contain substances of very high concern listed in Annex XIV of the regulation at a concentration of > 1g/kg.
  • If you use raw materials from suppliers outside the EU they may not be capable of answering. You will then have to use chemical analyses to measure the concentration of substances.

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PROFILE NO. 3: IF YOU TRADE IN FINISHED PRODUCTS (GLOVE-MAKING, SHOES, LEATHERWORK, CLOTHING, PPE), REACH AFFECH YOU AS AN IMPORTER AND/OR DISTRIBUTOR OF FINISHED GOODS. REACH considers all finished products to be an “article”.

What does REACH impose?

  • Determine whether the finished products you import contain substances of very high concern listed in Annex XIV of the regulation at a concentration of > 1g/kg.
  • If so, inform your customers of the fact immediately.
  • Keep any supporting documents that may be used to rule on the 1g/kg threshold for 10 years after the substance in question has stopped being marketed.
  • If you market finished products (to the general public) you have 45 days in which to answer any consumer questions regarding the presence in your products of substances of very high concern listed in Annex XIV of the regulation.

What you must do?

Write to your EU-based suppliers asking them whether the substances you buy from them contain substances of very high concern listed in Annex XIV of the regulation at a concentration of > 1g/kg.

If you use raw materials from suppliers outside the EU they may not be capable of answering. You will then have to use chemical analyses to measure the concentration of substances.

When?

As quickly as possible. The obligation to provide information will begin in late 2008/early 2009 when a Candidate List will be published of substances of very high concern listed in Annex XIV of the regulation.

Important!

From June 2011 for articles containing substances of very high concern listed in Annex XIV of the regulation at a concentration of > 1g/kg:

• if no company has registered the substance for this particular use with the European Agency.
AND
• if the total quantity of substance imported annually is > 1 tonne.

You must initiate notification proceedings with the European Agency that may result in a registration obligation. This procedure will be complex and expensive for the company.

3- WHAT SUBSTANCES TO LOOK FOR IN ARTICLES?

> 3.1 SUBSTANCES IN ANNEX XIV

Substances for which REACh insists information be provided are considered to be substances of very high concern and must be included in a list in Annex XIV of the regulation. The list does not exist as yet but will be created in two phases:

> Publication of a "candidate list" in late 2008/early 2009 as of when the obligation to provide information will begin for manufacturers-importers of articles.

> Publication in June 2011 of an official version called the "black list".

Not all substances that meet the criteria "of very high concern", i.e. several thousand, will be included in the list. The various countries in the European Union will suggest which substances are to be included. Initially, the "candidate list" should only therefore include several dozen of substances.

At present we do not know the substances in question. The list is open-ended and will be completed by June 2011 and then additions will be made little by little as the studies on substances are made public. In order to comply with REACh obligations to provide information, manufacturers and importers of articles will therefore have to reply to the following questions on a limited number of substances of very high concern in the "candidate list”:

> are these substances potentially present in my articles?
> if so, is the concentration higher than 1 g/kg?

3.2 WHICH SUBSTANCES THAT MEET THE CRITERIA OF VERY HIGH CONCERN ARE LIKELY PRESENT IN LEATHER, SHOE, TEXTILE-TYPE MANUFACTURED ARTICLES?

Because it is not yet known which substances are to be listed in Annex XIV, it is difficult to initiate information seeking procedures aimed at complying with the REACh obligations to provide information.

Using its business and technological intelligence systems and by sharing experiences with many material analysis laboratories CTC is, nevertheless, in a position to draw up a list of substances of very high concern that are potentially present in the following materials

  • leather,
  • textile (natural or synthetic fibre),
  • plastics (material with a coated fabric or sole).

The table below presents the major groups of substances identified to date for each material.

GROUP
TEXTILE
LEATHER
POLYMERS AND COATING
Acrylonitrile
-
-
ABS
Arsenic
X
X
-
AZO aromatic amines
*
*
-
Cadmium
-
-
*
Vinyl chloride monomer
-
-
PVC
Hexavalent chromimum (1)
-
*
-
Carcinogenic dispersed dyes
*
X
-
Short-chain chlorinated paraffins (C10–C13)
 *
-
Flame retardant (TRIS-OBDE) (2)
* (if PPE)
* (if PPE)
X
Formaldehyde (4)
*
*
-
Hexachlorobenzene
X
-
-
Organotin
X
X
X
PFOS/PFOA (2) and/or (3)
*
*
-
Phtalates (5)
-
-
*
- …Generally unnecessary
X…Possible presence, but in a low concentration
*…To be checked
(1)…Leather is tanned with trivalent chromium. Traces of hexavalent chromisum are sometimes detected in certain leathers.
(2)…Articles with fireproof properties
(3)…Articles with waterproof properties
(4)…If Europe persists with the protocol of classification as an established carcinogen
(5)List of 10 Phthalates
Even though at present we cannot know whether the substances in the above table will eventually be included in Annex XIV of the regulation we can, on the other hand, determine the scope of investigation that concerns the shoe and leatherwork industries.

The answer to the question: Are shoe or leatherwork-type goods likely to contain substances of very high concern? Is therefore YES.

The answer to the question: Are any of the substances likely to be present in a concentration higher than 1 g/kg? is not as simple.

Based on feedback from our test laboratory, it is nevertheless possible to identify certain substances that present a risk:

  • Phthalates which, when present, may be in concentrations considerably higher than 1 g/kg (mainly PVC soles, textile or leather coatings)
  • Formaldehyde that may be present in textiles in concentrations approaching 1 g/kg.

Faced with this problem, CTC is assessing the situation in order to:

  • improve knowledge of the phthalates associated with the industrial applications of the sector and possible alternatives,
  • and accurately identify the current bans on certain phthalates in order to answer the sector’s legitimate questions.

The results of this investigation will be presented to manufacturers at the Technical Commissions and briefings that the professional federations are due to organise in autumn 2008.

4- CONSEQUENCES OF REACH IN THE MEDIUM/LONG TERM ON MARKETING REQUIREMENTS OF FINISHED ARTICLES

The obligation to provide information that REACh has enforced will mainly affect article manufacturers/importers and distributors. The obligation to provide information is based on a 1 g/kg threshold which may be described as administrative.

The REACh regulation is also aimed at setting up Restrictions. The “administrative” threshold of 1 g/kg that imposes obligations to provide information does not reflect the existing limits currently in force. Take the example of aromatic amines that are regulated in the European Union: the authorised threshold for marketing is 30 mg/kg, which is the detection limit. If it becomes apparent that a substance may have damaging effects on consumers’ health or the environment at the end of an article’s life, the REACh regulation will therefore impose restrictions with thresholds much lower than 1 g/kg similar to those set up for carcinogenic aromatic amines.

The above information then takes on another meaning and could point to substances that could eventually be subject to restriction thresholds that are even less than 1 g/kg. The approach indissociable with REACh for all manufacturer-importers or distributors of articles is to establish a policy based on “Innocuousness” aimed at rendering the sourcing safe in terms of substances that are potentially dangerous for consumers or the environment. Such an approach could be based along the same lines as those applied for product quality standard development:

  • Taking stock of existing requirements and anticipating future requirements in your business sector,
  • formalising these requirements by drawing up suitable specifications,
  • enforcing these specifications prior to the procurement chain, particularly in countries in which the REACh regulation does not apply directly,
  • defining a self-inspection programme to ensure suppliers comply with requirements.

Follow the changes as they occur at www.ctcgroupe.com/reach

  
 
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