1 / 12

Compliance Guidelines for Manufacturers and Importers in EU

Learn about requirements and key questions for manufacturers and importers of articles in the European Union, including registration, notification, and information duties. Get insights on how to prepare for obligations and ensure compliance.

thane
Download Presentation

Compliance Guidelines for Manufacturers and Importers in EU

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Requirements and key questions for manufacturers and importers of articlesBerlin, 13 June 2006

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.

More Related