Intertek Regulatory Services

Transcription

1 Intertek Regulatory Services How Executive Management is redefining its Strategy regarding Regulatory Affairs Dr. Marc Thouin June 14th, 2011 Workshop Centro Reach 1

2 Eco-Management Topics REACH Restricted Substances Carbon Green Waste Alt./Renew Reduction Building Management Energy Green Packaging Sustainability Reporting Greenhouse Gas Reductions Recycling Issues on the radar screen of chemical companies Energy Efficiency Water Footprint 2

3 SCREAMING HEADLINES...?! 3

4 4

5 5

6 REACH impacts the entire value chain Raw materials Isolated intermediates Sales substances Downstream applications All chemical substances manufactured in or imported into the EU Includes downstream customer applications REACH affects all aspects of the chemical industry 6

7 Major changes and impact of REACH A single system for Existing and New substances - regulatory affairs Authorisation of substances of very high concern - product safety Encourage substitution of hazardous chemicals - research & development Making industry more responsible for safe use of chemicals - top management Extend responsibility along the supply chain - business operations REACH reaches deep into the organisation 7

8 AND The aim of REACH is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are eventually replaced by suitable alternative technologies where these are economically and technically viable Enforcement is now official and encouraged 8

9 Recent example of non-compliance What happens if the OR does not fulfil his obligations: Non-compliance is expensive 9

10 REACH Regulation EC No. 1907/2006 Title VII Authorisation 3 Chapters Chapter 1 Authorisation Requirement Chapter 2 Granting of Authorisations Chapter 3 Authorisations in the Supply Chain 12 Articles Annex XIV List of Authorised Substances Title XIV Enforcement 3 Articles Article 125 Tasks of Member States Article 126 Penalties for noncompliance Article 127 Report REACH requires (para)-legal skills 10

11 Substances of Very High Concern (SVHC) - Definition CMR substances Carcinogenic, mutagenic and toxic for reproduction substances meeting the criteria for classification in category 1A and 1B PBT and vpvb substances Persistent, bioaccumulative and toxic substances and very persistent and very bioaccumulative substances in accordance with criteria in Annex XIII Substances of equivalent concern with scientific evidence of probable serious effects, e.g. endocrine disruption REACH requires expert skills in chemistry, toxicology 11

12 Realities of REACH post registration Understanding what you are putting on the market (substance identification) forests of peaks Deciding on impact of Classification and Labeling (GHS) Communicating the uses - ALL uses (?) Authoring manageable extended SDS Monitoring the volumes in the market (upgrade) Connecting in the SIEF post registration Challenging costs of Letter of Access (LoA) Dealing with consortial management issues (entrants, exits) Updating the risk reduction measures (CSA, CSR) REACH continues to occupy us indefinitely 12

13 ECHA is serious: June 2010 An inspection program last year by regulatory authorities in European Union (EU) member states revealed that 24% of companies with obligations under the EU s Reach program were failing to comply with the legislation. Inspections were carried out between May and December About 2.6% of the almost 1,600 companies inspected were found to have infringed Article 5 of Reach, causing products to be removed from the market, and in 5.6% of cases the content of pre-registration dossiers was incorrect. In 11% of cases, safety data sheets (SDS) were not available, and in 20% of cases SDS s were not in compliance with language and formal requirements. The inspections formed part of Reach-en-force 1, an EU project designed to evaluate whether companies had met their obligations for Reach preregistration, including SDS-related requirements. The EU inspected 878 manufacturers; 666 importers; 83 only representatives; and 858 downstream users. Details of the inspections were released recently by the Forum for Exchange of Information on Enforcement, a group of EU memberstate representatives. Forum members say they plan further inspections of companies through spring 2011, to assess compliance with Reach following the first registration deadline of November 30, The forum also says it is making progress on plans to inspect chemical formulators for Reach compliance. REACH continues to occupy us indefinitely 13

14 ECHA is serious: June 2010 The European Chemicals Agency (ECHA) has announced that first inspection campaigns will focus on the following substances: ammonium dichromate and methylene diphenyl diisocyanate (MDI). Ammonium dichromate is used mainly as a chemical reagent and intermediate in the production of pigments, catalysts, chemicals, magnetic tapes, and as a mordant in dyeing. While MDI is widely used in the industrial production of rigid polyurethane foams. Both substances will be subject to a restriction in Annex XVII of REACH from 28 December 2010 REACH continues to occupy us indefinitely 14

15 ECHA is serious: January 2011 The European Chemicals Agency (ECHA) has announced that last week the coordinators of national inspectors were trained on the REACH and CLP duties of downstream users of chemicals to ensure such users comply with their responsibilities to inform consumers about substances in mixtures. The training was organised within the framework of the second coordinated European enforcement project for REACH and CLP, and inspections at national level will start in summer REACH continues to occupy us indefinitely 15

16 ECHA is serious: April 2011 The European Chemicals Agency (ECHA) has provided some additional information to its recently published draft work programme further detailing the expected influx of registration dossiers between 2012 and 2014, and expected revenues from registration, authorisation and classification and labelling, as well as appeals, during the period. For the years 2012, 3013 and 2014 the agency anticipates receiving 5,100, 13,300 and 6,500 dossiers including updates. It says these figures, which are based on the original estimates made by the European Commission and assume that registrations are updated at a rate of 10%/year for phase-in and 20%/year for non-phase-in substances. It also includes additional updates assumed to arrive following compliance checks. REACH continues to occupy us indefinitely 16

17 Prepare for the new reality Invest to understand the health, safety and environmental issues appoint an HSE officer Hire, build or buy-in people with competent skills to support Ensure you are compliant document your processes Communicate the registered uses downstream interact with DU and record Author compliant Safety Data Sheets integrate Exposure Scenarios (e-sds) Stand-up to defend your position use every trick of the trade REACH is here to stay face it 17

18 Industry has to change its attitude Ronald Drews, vice president of chemical regulations and trade control at BASF said that the presumption that the hard work was done meant those working on REACH had to fight for resources to ensure that they could continue moving towards future deadlines. He noted that after the 2010 deadline lots of people thought that REACH was finished. He commented that even if the next deadline isn t until 2013 we can t sit back, work has to continue. We need to constantly educate our managers that REACH goes on and that there could be more challenges. We will have more substances to register [in 2013] and the data will be poorer. REACH requires a change of mind-set 18

19 Every Challenge is an Opportunity to Excell visit: /ies 19

20 Valued Quality. Delivered. 20