Updated Information On Reach – May 2013
Dr. Varalakshmy Chaudhari
Manager – sustainability services
SGS India Private Limited,
Reach is the European Union Chemical Regulation (EC) N°1907/2006 governing the registration, evaluation, authorization, restriction of chemicals.
Under Reach directive, All manufacturers, importers and distributors of chemical substances, preparations and Articles shall ensure that they manufacture, introduce to the market or use substances that have no harmful effect on human health or the environment.
Upon request, manufacturers and importers must submit a statement on the Very High Concern (SVHC) contained in their products. A report shall be submitted to the European Substances of Chemicals Agency EHCA if a product contains more than 0.1 percent of hazardous substances by weight. Currently 138 Substances of very high concern are covered under above obligation.
Please find below some recent updates on the regulations that affect leather and foot wear goods exported from India into EU countries.
Public Consultation on 10 of Very High Concern
The principle of the Candidate List is that products must be scrutinized for presence of substances of very high concern (SVHC) Currently 138 chemicals listed on the SVHC list that are subject to the requirements of notification.
Substances covered under reach Candidate List are:
- substances that meets the criteria for classification as a carcinogen, mutagen, or toxic for reproduction category 1 or 2
- substances classified as persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative endocrine disruptors,
Currently ECHA is considering inclusion of 10 substances in candidate list. Comments on 10 substances proposed to be included in the Candidate List was open for 45 days and ended on 18 April 2013.
ECHA will consider this information later in the process when recommending SVHCs for inclusion in the Authorisation List (Annex XIV).
Substances proposed for identification as an SVHC and the reasons for their proposal:
| Substance name | EC number | CAS number | Proposed SVHC property |
|---|---|---|---|
| Cadmium oxide | 215-146-2 | 7440-43-9 | Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f) |
| Dipentyl phthalate (DPP) | 205-017-9 | 131-18-0 | Carcinogenic (Article 57a); Equivalent level of concern having probable serious effects to human health (Article 57 f) |
| Nonylphenol, branched and linear, ethoxylated [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof] | - | - | Toxic for reproduction (Article 57 c) |
| 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) | 253-037-1 | 36437-37-3 | vPvB (Article 57 e) |
| 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) | 247-384-8 | 25973-55-1 | PBT (Article 57 d); vPvB (Article 57 e) |
| 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) | 223-383-8 | 3864-99-1 | PvB (Article 57 e) |
| 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) | 223-346-6 | 3846-71-7 | PBT (Article 57 d); vPvB (Article 57 e) |
| Ammonium pentadecafluorooctanoate (APFO) | 223-320-4 | 3825-26-1 | Toxic for reproduction (Article 57 c); PBT (Article 57 d) |
| Pentadecafluorooctanoic acid (PFOA) | 206-397-9 | 335-67-1 | Toxic for reproduction (Article 57 c); PBT (Article 57 d) |
Further information on Current Candidte list of 138 svhc can be accessed at below link
http://echa.europa.eu/web/guest/candidate-list-table
Communication in the Supply Chain ( Article 33):
Producers, importers and other suppliers of articles containing SVHC included in the Candidate List in a concentration above 0.1% (w/w) have to provide information about the SVHC to the recipients of the articles.
According to Article 33, the information can be automatically provided, or it must be available upon request by consumers, free of charge and within 45 days.
This information shall ensure safe use of the article and as a minimum shall include the name of the substance. The information can be provided by different means to the customer, including in sales literature, on a website or in separate communications
Notification:Notification of a substance will be required, by European customers, for Substance of Very High Concern (SVHC) that is included on the “Candidate List”and not already registered for the use.
As of 1 June 2011, producers and importers are required to notify the ECHA when a SVHC in the Candidate List is present in their articles above a concentration of 0.1% (w/w) and in an amount totaling over 1 tonne per year per producer or importer. Notification can lead to a requirement for registration.
Restrictions on the use of certain substances
Restriction list under Annex XVII of the Reach Regulation replaces the former Directive on the ‘Marketing and Use of Dangerous Substances’ . It continues to restrict the use of certain substances in specified uses with certain limits – for example certain azo dyes , Nickel, Lead and Cadmium , nonylphenol ethoxylates etc.
Restrictions under consideration
This table shows the ongoing public consultations of the restriction proposals.
| Substance Name | EC Number | CAS Number | Consultation on restriction report | Deadline for comments on restriction report | Consultation on SEAC draft opinion | Deadline for comments on SEAC draft opinion |
|---|---|---|---|---|---|---|
| 1,4-Dichlorobenzene (p-dichlorobenzene) | 203-400-5 | 106-46-7 | Consultation is now over | 19/12/2012 | Give comments | 17/05/2013 |
| Lead and lead compounds in articles intended for consumer use | 231-100-4 | 7439-92-1 | Give comments | 21/09/2013 |
PRODUCT SAFETY MONITERING IN EUROPEAN COUNTRIES:
The General Product Safety Directive (GPSD) lays down product safety requirements for non-food consumer products and has established a alert system on dangerous products (RAPEX).
The GPSD also defines the respective requirements of business and national authorities: manufacturers are required to place only safe products on the market and Member States must take the necessary measures to enforce the requirements on producers and distributors.
Action is taken against dangerous products, If products are identified as potentially dangerous for the health and safety of European citizens, corrective actions can be taken at three different levels:
In addition to supplying safe products, Producers / importers must take all necessary measures to prevent the risks associated with the products they supply. Producers and distributors must also be able to trace dangerous product and have to inform the competent national authority when they are aware that a product they have placed on the market is dangerous.
Member States are responsible for verifying that product safety rules are implemented properly. They appoint national surveillance authorities which check that products sold on their market meet all safety requirements and have the power to take corrective actions, ask for product recalls and impose penalties.
Member State level (RAPEX): When a product is found to be dangerous, the competent national authority takes appropriate action to eliminate the risk. It can withdraw the product from the market, recall it from consumers or issue warnings. The national contact point of RAPEX then informs the European Commission about the product, the risks it poses for consumers and the measures taken. The European Commission disseminates the information through RAPEX to all other Member States,which can swiftly take appropriate action.
in one EU country is quickly circulated to the othercountries and to the European Commission for appropriate follow-up. The Commission is responsible for coordinating the network and publishes weekly online overviews of all the notifications made, freely accessible on its website.
It also publishes a series of statistics on the number of notifications, the product categories, the nature of risk, and the countries of origin.
SOME DATA FROM CURRENT REACH RECALLS ARE ATTACHED FOR REFERENCE BELOW:
| Notifying country | Product | Danger | Measures adopted by notifying country |
|---|---|---|---|
 Bulgaria | Product: Ladies’ shoes Brand: Megias Description: Ladies’ shoes in moccasins style. The inner sole and the upper shoe are made of leather. Country of origin: Turkey | The product poses a chemical risk because it contains 6.3 mg/kg of chromium (VI) in the leather part. Chromium (VI) is classified as sensitising and may trigger allergic reactions. | Compulsory measures: Ban on the marketing of the product. |
 Germany | Product: Leather insoles Brand: Unknown Description: Leather insoles. One-size which can be cut to size. Country of origin: China | The product poses a chemical risk because it contains 16 mg/kg of chromium (VI). Chromium (VI) is classified as sensitising and may trigger allergic reactions. | Voluntary measures: Withdrawal of the product from the market. |
 Germany | Product: Babies' shoes Description: Babies' shoes in light blue leather. A piece of white elastic is incorporated at both sides in the region of the ankle. The sole is made of light-coloured leather. Packaging: transparent plastic bag with a tab for hanging; printed cardboard label inside the bag, as well as a leather-look cardboard label. Country of origin: China | The product poses a chemical risk because it contains chromium (VI) at levels of 98.7 mg/kg and 97.6 mg/kg in the sole. Chromium (VI) is classified as sensitising and may trigger allergic reactions. | Voluntary measures: Withdrawal of the product from the market. |
 Hungary | Product: Men's leather wristband Description: Man's black leather bracelet. The bracelet consists of two braided straps that are fixed with a leather cord at two points. The product is without packaging. Country of origin: India | The product poses a chemical risk because the leather wristband contains azo dyes releasing 590 mg/kg of benzidine. The product does not comply with the REACH Regulation. | Compulsory measures: Withdrawal of the product from the market and recall of the product from end users. |
 Germany | Product: Leather gloves Name: Rekawiczki Skorzane Damskie (Leather gloves) Description: Grey coloured, leather-textile women`s gloves, sizeM. Country of origin: China | The product poses a chemical risk due to the presence of 225 mg/kg of Chromium (VI). Chromium (VI) is classified as sensitising and may trigger allergic reactions. | Voluntary measures: Withdrawal of the product from the market. |
 Germany | Product: Golf glove Brand: Foot Joy Description: Black glove with velcro fastening made of a textile and leather combination. Packaging: plastic casing. Country of origin: Vietnam | The product poses a chemical risk because it contains 50 mg/kg of Chromium (VI). Chromium (VI) is classified as sensitising and may trigger allergic reactions. | Voluntary measures: Recall of the product from end users |
 Hungary | Product: Leather jacket Brand: C&A Description: A leather jacket comprising several brown leather pieces sewn together, with a patterned, ochre-coloured textile lining and various zips and pockets; size 40. Country of origin: Pakistan | The product poses a chemical risk because it contains 11.8 mg/kg (brown leather, jacket back) and 28.2 mg/kg (brown leather, inside collar) of Chromium (VI). Chromium (VI) is classified as sensitising and may trigger allergic reactions. | Voluntary measures: withdrawal of the product from the market. |
 Bulgaria | Product: Men's leather wristband Brand: SIX Description: Black, men's leather bracelet with four rivets (4 cm wide). No packaging. Country of origin: China | The product poses a chemical risk because it contains azo dyes releasing 48.9 mg/kg of benzidine of the leather. This exceeds the limit of 30 mg/kg. The product does not comply with the REACH Regulation. | Compulsory measures: Withdrawal of the product from the market |
 France | Product: Men’s shoes Brand: W Vitto Description: Men’s shoes made of genuine leather, with shoelaces. The upper is made of genuine leather in black, the lining and the insole are made of genuine leather and the sole is made of thermo rubber. Country of origin: Turkey | The product poses a chemical risk because the lining contains 8.9 mg/kg of chromium (VI) and the insole contains 6.8 mg/kg of chromium (VI). Chromium (VI) is classified as sensitising and may trigger allergic reactions. | Compulsory measures: Import rejected at border |
 Cyprus | Product: Gardening gloves Brand: AJS - Le jardin en couleurs Description: Gloves made of blue material with white floral print and white leather on the palm, with adjustable self-adhesive closure. Gloves have no marking. Country of origin: China | The product poses a chemical risk because the leather contains 15.2 mg/kg of Chromium (VI). Chromium (VI) is classified as sensitising and may trigger allergic reactions. The product does not comply with the Personal Protective Directive and the relevant European standard EN 420. | Voluntary measures: Withdrawal of the product from the market, recall from end users and destruction of the product. |
Way forward to complaince
Unlike other regulations, Reach is a dynamic regulations with new updations happening twice in ayear Under this the rapidly changing scenario regarding Reach restricted chemicals and svhc compliance ,a thorough understanding is required by export community to avoid pit falls and to continue exports to European countries in a smooth manner.
| High risk materials found in Leather | |
|---|---|
| Allergenic and sensitising dyes | Dimethyl formamide |
| Chlorinated phenols (PCP, TeCP and TriCP) | Tris(2-chloroethyl)phosphate (TCEP) |
| Alkanes, C10-13, chloro (SCCP) | Chromium (VI) |
| 4-tert-Octylphenol | Dimethyl fumarate |
| 2-Methoxyaniline | Sodium dichromate / Potassium dichromate / Ammonium dichromate |
| DEHP / BBP / DBP / DIBP / DHNUP / DIHP / DMEP /DINP/DIPP | Chromium trioxide |
| Acid generated from chromium trioxide and their oligomers | Volatile organic substances (VOC) (air emission) |
| 4,4'-Bis(dimethylamino)-4''-(methylamino)trityl alcohol | Formaldehyde, oligomeric reaction roducts with aniline (technical MDA) |
| Nonylphenol ethoxylate and nonylphenol | Lead chromate / C.I. Pigment Yellow 34 / C.I. Pigment Red 104 |
| Organotin compounds | Sodium chromate / Potassium chromate |
| Phthalates | Heavy metals |
| Boron containing substances | N-methyl pyrrolidone |
| Azo amines | Acetaldehyde (air emission) |
| Brominated organic flame retardants | Biocides (air emission) |
| Polyaromatic hydrocarbons (PAH) | Michler's ketone / Michler's base |
| Perfluorooctane sulfonate (PFOS) | C.I. Basic Violet 3 / C.I. Basic Blue 26 |
| Chlorinated paraffins (short chain, C10 | C 13, SCCP) | |
Compliance Strategy must be formulated with study of Risk Assessment parameters vs products used and, combined supplier trainings, random testing scheme for highrisk SVHC / RS testing with a substitution strategy in view
SGS offers a comprehensive suite of services to help our customers comply with their obligations under REACH, from initial REACH registration to consulting, testing, auditing and verification services to support ongoing compliance.
For more information on REACH,
please do not hesitate to contact
SGS India Pvt Ltd: http://www.reach.sgs.com
Leather business queries : p_venkatesan@sgs.com (09003080029)
India Reach contact : varalakshmy.chaudhari@sgs.com (09324264318)