SEMINAR “The impacts of EU Legislation REACH on Textile & Clothing Industries” October 28, 2008 ITKIB – Istanbul By Adil ELMASSI Director Environmental Affairs

 Do I need to pre-register and register substances in articles?  Do I need to notify substances in articles?  Do I need to forward information on substances in articles to my customers or to the consumers? The application of substances in articles provisions is a serious challenge for EU importers of yarns, fibres and grey fabrics as well as finished articles WHY? Lack of information on the production process and the corresponding chemicals input

Substances in Articles Obligations–EU Importers Registration according to article 7(1)  Intended release  Total amount exceeds 1 t/a  The total amount of the substances in all articles is taken into account  If more than one type of articles with intended release of that substance, the quantities in all articles have to be summed up  The substance does not have to be registered if already registered by an actor in the supply chain

Notification according to article 7(2) Only when all conditions are met:  The substances is included in the candidate list for authorisation (article 59(1))  Is present in all articles in amount totalling over 1t/a  Is present in the articles above 0.1% (w/w) Notification is not requested if one of the following conditions is met:  Exposure is excluded  The substances has already been registered for the use in the article

Notification according to article 7(2) IMPORTANT to note 0.1%(w/w) threshold is applied to an article as imported and not to the homogeneous parts of an article Substances being part of imported articles cannot be subject to authorisation

Duty to Communicate Information on Substances in Articles - Obligation according to Article 33  Articles 33 ensures that sufficient information is communicated with articles to allow safe use  Information has to be also provided to consumers upon request within 45 days  It concerns SVHC present in the article in concentration above 0.1%  The obligation cannot be exempted via article 7(3) (exclusion of exposure)  The obligation cannot be exempted via article 7(6) ( already registered for that use)

Obligations according to Article 33 IMPORTANT to note There is no tonnage trigger for this obligation The obligation applies once SVHC has been included on the candidate list for authorisation The date of supply of articles is relevant The obligation apply also to articles which were imported before the substance was included in the candidate list and are supplied after the inclusion in the that list

RESTRICTIONS  The content of substances in imported articles can be restricted or banned  Importers of articles has to follow the conditions outlined in annex XVII of REACH from the 1 June 2009

Table 1 : Timelines for Article Importers Potential obligations for article suppliersTime Start of obligation to register non-phase-in substances and phase-in substances which have not been pre-registered, if conditions of Article 7.1 are met From 1st June 2008 Pre-registration off phase-in substances if they need to be registered according to Article 7.1 or according to Article 6 (e.g. subtances imported in preparations) 1st June 2008 – 1st December 2008 Participation in SIEFs (potential registrants according to Article 6 and 7.1)1st June, after pre- registration  Communication about substances on the candidate list in articles according to Article 33 After publication of candidate list (first list expected autumn 2008/beginning 2009) Notification of substances in articles according to Article 7.26 months after substance is included in candidate list. No notification required before 1st June 2011 Registration of pre-registered phase-in substances in amounts ≥ 1000 tonnes per year or more, in amounts ≥ 1 t/a if the are known carcinogens, mutagens or reprotoxic substances (category 1 and 2) and in amounts ≥ 100 t/a substances if they are classified with R50/53  By 30th November 2010 Registration of pre-registered phase-in substances in amounts between 100 and 1000 tonnes per year By 31st May 2013 Registration of pre-registration phase-in substances between 1 and 100 tonnes per year By May 2018

Packaging and containers  Importers of packaged articles have to fulfil the same requirements for that packaging as for any other article, be it a carton or a plastic wrapping  In general no intended release from packaging materials is foreseen but they may be unintended release.

Be Prepared to communicate Information to your EU Customers Article Suppliers to the EU:  Should document the results of their compliance checking with the requirements of substances in articles and information to consumers  With implemented Environmental management systems could incorporate REACH conformity as a criterion with a clear indication of how conformity will be secured and documented  May establish “good practice code” with supporting documents including letters to importers, certificates, results of analysis etc.

Standardised information from non-EU suppliers Part of the information needed to comply with Art 7 & 33 can be derived from the SDS (art 31) or information required for substances subject to authorisation /restriction for which no SDS is required ( Art.32) Article importers will not receive any comparable standardised information ( supply chain outside the EU)

Requesting non-standardised information  In this case you will face an active request for information on the identity of the SVHC and on the concentration/amount contained in the articles I M P O R T A N T to note  The textile supply chain is complex, confidentiality and contractual obligations may hinder communication and information flow.  This type of enquiries will need time and resources and concertation between the actors

NON-EU Exporters can play a role in facilitating the process and reducing the work load Excluding the use of SVHC: This could be done “top down”: by certifying that SVHC are not used or remain under certain concentration range in articles. The “bottom up” approach consist of EU importer including criteria in supply contracts

Recommendation for a strategy to consider 1. Narrow down the range of SVHC in the candidate list by using the “ exclusion” approach 2. Consider 0.1% (trace amounts would normally not exceed the threshold) 3.Consider when relevant the 1t/a threshold (substances in articles requirement) 4. Exhaust options for obtaining information via your supply chain 5. Only as last resort conduct targeted analysis

Determining whether the article contain SVHC  Be aware of the possibility to accumulate SVHC through the production process  If the exact concentration in the article is not known, a first screen may be performed on the basis of the maximum amount or concentration in the article. If it shows a concentration > 0.1% a more precise determination of the SVHC amount or concentration should be made

Excluding exposure for substances in articles Exposure can be excluded in the following situations:  No release occur  There is a release but the article is embedded during use and the substance will not escape to the environment or get into contact with humans during use and disposal

Excluding exposure include arguments based on:  Knowledge of the article and its service life  Knowledge on the substance properties  Quantification based on exposure models demonstrating no exposure during the life cycle and disposal  Measurements proving that no emission from the article take place including during its disposal It maybe more difficult and more expansive to “exclude exposure” than making a notification to the Agency

Thank you for your attention Adil ELMASSI Director ENVIRONMENTAL AFFAIRS EURATEX