Requirements and key questions for manufacturers and importers of articlesBerlin, 13 June 2006
Introduction I Definition ‘Article’: An object which during production is given a special shape, surface or design which determines its function to a greater degree than does its technical composition. Definition ’Preparation‘: Mixture or solution composed of two or more substances.
Introduction II Obligations: • Registration of substances intended to be released from articles • Notification of substances of very high concern present in articles • Communication of information about substances of very high concern present in articles
Furthertestsrequired End of test End of test Registration Notification Information General Application of Article 6 Are my articles covered by the exemptions? • Food • Animal nutrition • Medicinal products • Biocides • Substances covered by Annexes II and III Is my company a manufacturer or importer of articles to the EU? No No Yes Yes
Further tests required: notification Information from suppliers, or analyses, if required Registration Notification Information General Article 6.1 – Registration I Are the substances in my articles intended to be released? No No Do I know the released substances? Yes Yes Examples of articles: • Scented candles • Cleaning cloths • Pencils
Substance already registered for this application? End of test No No Yes Yes Registration Notification Information General Article 6.1 – Registration II Is the total quantity of a substance (totalled over all articles) higher than 1t per year? Pre-re-gistration beginning of 2008! • Manufacturer • Substance identity • Tonnage band Does the substance constitute a so-called phase-in substance? Common registration: Time schedule depends on other registrants
End of test End of test No No Yes Yes Registration Notification Information General Article 6.2 – Notification I Are substances of very high concern present in my articles? Is the concentration of the substance higher than 0.1%? Carcinogenic, mutagenic or teratogenic substances, listing on the candidate list
Further tests required: Informationobligations End of test No No Yes Yes Registration Notification Information General Article 6.2 – Notification II Notification from mid- 2010: • Manufacturer • Substance identity • Classification • Use • Tonnage band Can the exposure of humans and the environ- ment not be excluded? Is the total quantity of a substance (totalled over all articles) higher than 1t per year? After listing on the candidate list, 6 months time for notification, after 3.5 years at the earliest
End of test End of test No Yes Registration Notification Information General Article 30.4 – Information Duty to communicate informationto recipient from mid-2010: • Information about safe use • At least the substance name Are substances of very high concern present in my articles? Is the concentration of the sub-stance in the article higher than 0.1%? No Yes Recipient = professional recipient
How to prepare yourself? I • Check who is the manufacturer / importer as specified by the Regulation. • Preparation of a list of all relevant articles. • Assistance in sectoral or overlapping teams, which develop concrete applications and guidelines. • Prioritization of the internal implementation tasks according to the time sequence of obligations. • Pre-registration, notification and duty to communicate information, registration
How to prepare yourself? II • Pre-registration already by early to mid- 2008 • Identification of all manufactured and/or imported articles that are intended to release substances (primary function). • Information acquisition from suppliers or conducting own analyses. • Making data available for pre-registration. • Communication with potential consortium partners who prepare the common registration dossier.
How to prepare yourself? III • Identification of the articles containing substances of very high concern >0.1% w/w • Identification of all manufactured and/or imported articles. • Clustering of articles in categories and identification of potential, relevant substances. • Check against existing substance prohibitions (azo dyes in textiles, heavy metals in electrical appliances, etc.). • Organization and extension of information flow to and from the suppliers.