EU REACH Regulation

1. EU REACH Regulation SVHC under REACH

2. The EU’s Black-List • The Commission established a separate procedure for chemicals that possibly cause severe impacts on human health or the environment • In order to be sold in the EU or used in products sold in the EU, these chemicals would have to obtain special Authorization. • The EU Chemical Agency (“Agency”) would first develop a “candidate list” of substances to be authorised and • prioritize its order of authorisation basing on concerns and consumption

3. SVHC – what it stands for SVHC are: Substances of Very High Concern require authorisation for use, special attention and reporting on: • Manufacturing • Storage • Shipment • Use • disposal

4. The “CMRs” Article 57 of 2006/121/EC (REACH Directive): So called CMR-Substances • Carcinogenic and/or • Mutagenic and/or • Toxic toReproduction either category 1 or 2 according to 67/548/EC

5. The “PBTs” Article 57 of 2006/121/EC (REACH Directive): So called PBT-Substances • Persistent and /or • Bio-accumulative and/or • Toxic in accordance with the criteria set out in Annex XIII of the REACH directive This group includes the vPvB (very persistent and very bio-accumulative) Substances

6. SVHC – what are they? Substances of Very High Concern are for instance: • Polycyclic Aromatic hydrocarbons (PAHs) and aromatic hydrocarbons found in resins, oil distillation products, tars, etc • Azo-Dyes used for textiles, leather and food colours • Some toxic metals such as Mercury, Lead, Chromium, Antimony, Beryllium, Arsenic found in alloys, colours, ceramic products, coatings, etc. • Halons still used in coolants, refrigerators, solvents • Halogen Carbonhydrates used in fire retardants like TBBA, other Bromium-compounds, fluorinated compounds, etc. • Some monomers for plastics like Vinylchloride, etc.

7. Where to look at (1) SVHC can be found • Among Substances:examples: Halons, Polycyclic Aromatic Hydrocarbons, DDT, Azo-Compounds, Nitrosamines, Metal organic compounds, etc… • In Preparations:examples: varnishes containing halogenated solvents and PAHs, alloys containing toxic metals like Lead, Arsenic, Antimony, Chromium, etc; Dyes containing inorganic or organic pigments (Cadmiumsulfide-Yellow, Azo-pigments, Chromium IV-Green) Note: typically any mixture that is intended to undergo a chemical reaction (e.g. resins, epoxies, ) can potentially contain SVHCs

8. Where to look at (2) But also articles may contain SVHCs • Coatings of products, • Glues, resins and fillers in composites, • Alloys in metal products, • Fire retardants and monomers in plastic parts (e.g. TBBA as flame retardant), • Lubricants in mechanical parts, Be aware and watch out for hidden SVHC’s in products you plan to bring in.

9. The Threshold Note: any content >0,1% w/w or 1.000kg (1mt)/a of imported SVHC will require authorisation!

10. Authorisation of SVHCs • I. “Individuals” engaged in the authorisation process  Identification • II. Duties  Distribution • III. Application for authorisation  Content

11. I. “Individuals” in authorisation process  Identification • Applicant (Manufacturer or importer) • EChA (as the central data host and exchange port and as part of authorisation chain) • Commission (as the „decision-maker“) • National Competent Authorities (as the final executive organ) Other parties may be pulled in as the authorities feel appropriate: • Consumers? • Interested Parties? • Other affected parties

12. II. Duties  Distribution • Applicant: applies for an authorisation (Art. 62 I) • EChA: receives application (Art. 62 I) • Commission: decision on application for authorisation (Art. 60 I) • National Competent Authorities: enforces authorisation or prohibition of substance use Again: Other parties may be pulled in as the authorities feel appropriate: • Consumers? • Interested Parties?

13. III. Application for authorisation  Content Art. 62 IV, V: • identification of substance and applicant • uses of the substance for which authorisation is sought:detailed description of the use and function of the substance in that use • Chemical safety report:following the CSR from registration • Analysis of alternatives: detailed replacement asessment and results, if replacement possible: detailed substitution plan; if not: detailed reasons why • Socio-economic analysis

14. Additional Requirements For SVHC detailed information are required for entire product life span: • Exposure Scenarios and Risk Descriptions for registered/authorised uses covering the entire life span of the chemical, • Detailed description of registered/authorised uses plus warnings for unauthorised uses • Detailed description of Risk Management Measures also covering entire life span

15. Risk • Starting of June 2008 the ECHA works on the list of SVHC candidates • June 2009: the ECHA proposes a procedure for authorisation (Amendment XIV) • PBT and vPvBT as well as CMRs will directly become subject to authorisation • Even in case of authorisation limitations on use of SVHCs extremely likely (e.g. volumes, applications, specal safety measurements, phase out period, ...)

16. Target List to NGO’s? The List of SVHCs requiring authorisation certainly will appear on the radar of groups (e.g. some NGOs) generally hostile to chemical use of Substances. There is a real risk that these groups may influence governments to force companies not using these substances at a time where: • they have not gone through a proper risk assessment, • REACH blocks their lawful use without authorisation, and • they have not yet gone through the authorisation process.

17. How to get through? • Start a stringent data mining and evaluation process • Define what is „critical“ to your business in particular (e.g. special process steps, special chemicals, sole source supply, etc) • Establish data processing capabilities • Create a detailed inventory of chemicals, processes and their implications • Evaluate data to find critical issues • Work on critical paths • See also morning session and/or later

18. Thank You For Your Attention Please Feel Free To Ask Any Questions