REACh. The new European substances legislation. TANATEX Chemicals REACh

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1 REACh The new European substances legislation TANATEX Chemicals REACh

2 REACH REACH REGISTRATION EVALUATION AUTHORIZATION of CHEMICALS TANATEX Chemicals REACh Slide 2

3 History Chemicals can only be produced (used) if there is sufficient information available about its property (physical, toxicity, environmental influence etcetera). REACh makes industry bear most responsibilities to manage the risks posed by chemicals and provide appropriate safety information to their users. Consumer associations and environmental organizations demand clarity about the dangers and risks of chemicals for man and environment. The European Union takes into account this demand and made up the REACh regulation (1907/2006/EC). TANATEX Chemicals REACh Slide 3

4 The aims of REACh Improve the protection of human health and the environment from the risks that can be posed by chemicals. Enhance the competitiveness of the EU chemicals industry, a key sector for the economy of the EU. Promote alternative methods for the assessment of hazards of substances. Ensure the free circulation of substances on the internal market of the European Union. TANATEX Chemicals REACh Slide 4

5 REACh refers to substances Substances are pure raw materials that can be described by a CAS or EINECS number. REACh refers not to: preparations, but certainly to the pure raw materials of these preparations; substances that comply with the definition of polymers; some well defined naturally occurring substances. TANATEX Chemicals REACh Slide 5

6 REACh procedure Pre-registration - Gather relevant substance specific information: physical-, toxicological- and ecotoxicological properties and intended use. - Compile Chemical Safety Report: exposure scenario, chemical safety assessment and additional tests. - Evaluation by European Chemical Agency (ECHA). TANATEX Chemicals REACh Slide 6

7 Data requirements The data requirements depend on produced or imported quantity 1 10 t/a t/a t/a > 1000 t/a D a t a r e q u i r e m e n t s Annex VII Annex VII, VIII Annex VII - IX Annex VII - X T e c h n i c a l D o s s i e r C h e m i c a l S a f e t y R e p o r t TANATEX Chemicals REACh Slide 7

8 Evaluation and registration When a substance is evaluated by ECHA and there are no unacceptable risks, this substance may officially be produced and used for the application as described by the registration. The substance is registered and gets a registration number. TANATEX Chemicals REACh Slide 8

9 Time schedule 1 June 2007 : The REACh regulation comes into force 1 June 2008 : Start pre-registration 30 November 2008 : End of pre-registration 30 November 2010 : Registration of: 31 May 2013 : Registration of: 31 May 2018 : Registration of: - CMR category 1+2 (> 1 T/Y) - R50/53 substances (>100 T/Y) - Substances (>1000 T/Y) - Substances ( T/Y) - Substances (1-100 T/Y) TANATEX Chemicals REACh Slide 9

10 REACh is not unique in the world! At the moment there are at least 8 countries / regions with comparable substance legislation: United States : TSCA Korea : KECI Canada : DSL/ NDSL Philippines : PICCS Australia : AICS China : IECSC Japan : MITI New Zealand : ERMA TANATEX Chemicals REACh Slide 10

11 What REACh means for preparations Most of the products TANATEX Chemicals delivers to its customers are preparations of several substances. REACh regulation is not applicable to preparations, however preparations may only consist of substances that are registered under REACh. If a substance is not registered it may not produced and can not be used in preparations. The last substances will be registered in May Only after that date we can state that all our preparations consist of registered substances. TANATEX Chemicals REACh Slide 11

12 MSDS and labeling New demands on the Material Safety Data Sheet and labeling : The MSDS has to comply with REACH: chapter 2 and 3 of the MSDS will be reversed (Paragraph 32) when the MSDS is actualized : The current regulation will be replaced by the GHS (Global Harmonized System). From 2010 : The Chemical Safety Report will become part of the MSDS when the MSDS is actualized (only for products classified as hazardous). All MSDS for existing products are still valid until the end of The requirements regarding the contents of the existing MSDS comply with the requirements in the REACh regulation. TANATEX Chemicals REACh Slide 12

13 Obligations TANATEX TANATEX has to pre-register and register: all substances that are produced on our sites. (raw) materials that we import from outside the EU. TANATEX Chemicals REACh Slide 13

14 Obligations TANATEX and customers Besides this, we have asked our suppliers if they are going to (pre)register their products (substances) for the applications we support. We will inform our customers for which intended use we shall register our chemical products. If this deviates from their use they have to inform us so we can also support this intended use in the Chemical Safety Report. REACh is a cooperation between supplier, producer and customer! The responsibility lies with everyone. TANATEX Chemicals REACh Slide 14

15 Important information for customers REACh refers to substances and not to products. Products shall not be registered within REACh and therefore do not receive a REACh registration number. TANATEX has pre-registered all relevant substances manufactured in - or imported to - the EU under REACh. TANATEX has asked all its suppliers of REACh relevant substances to confirm the pre-registration their substances. In principle our current product portfolio for the current applications will be maintained. TANATEX Chemicals REACh Slide 15

16 More information Our Quality, Health, Environment and Safety Department will ensure that all deadlines and requirements are fulfilled. Questions? Contact our REACh-team at TANATEX Chemicals REACh Slide 16

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