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Guideline for REACH Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (EC) No.1907/2006 Guideline for REACH Registration,

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Presentation on theme: "Guideline for REACH Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (EC) No.1907/2006 Guideline for REACH Registration,"— Presentation transcript:

1 Guideline for REACH Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (EC) No.1907/2006 Guideline for REACH Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (EC) No.1907/2006 ★ As of June 2008, registration or notification is required for all chemical substances sold in the EU. No data, No market! Japan Construction Equipment Manufacturers Association Ver.1 2008.10.8

2 [Table of Contents] 1. Simplified Flow Charts of REACH Regulation Compliance 2. Registration and Pre-registration 3. Examples of Preparations Handled by Construction Equipment Manufacturers 4. Examples of “Substances Intended to be Released from an Article” Handled by Construction Equipment Manufacturers 5. Who Registers and Who Can Register 6. Examples of Restricted Substances Handled by Construction Equipment Manufactures 7. Obligations Regarding SVHC 8. SVHC 9. Schedule for REACH Enforcement This guideline was created as a summary of the matters to be carried out by construction equipment manufacturers from outside the EU doing business in the EU, to facilitate the industry’s smooth compliance with the REACH regulation. Be sure to consult the actual text of the regulation for details.

3 Flow Chart 1 Confirming the need for REACH regulation compliance and product classifications START No action required Is the exported product a ”preparation” (2) or an “article” (3) ? 1. Simplified Flow Charts of REACH Regulation Compliance Do you export to EU members a product (1) made or sold outside the EU region? Go to Flow Chart 2 (Preparations) Go to Flow Chart 3 (Articles) (1)Includes not only the machinery itself but also supplies provided with it such as service parts and hydraulic oil. (2)A mixture or solution of two or more substances. This applies to hydraulic oil, grease, paint, window washer fluid, etc., when exported separately. (3)The machinery itself, and also service parts, etc., that are exported. No Yes PreparationArticle This flow chart was created to provide vendors manufacturing or selling outside the EU region with a simple way of determining their need to comply with the REACH regulation. If the possibility of such a need is indicated, be sure to check the text of the regulation itself when studying how to comply.

4 Flow Chart 2 Vendors Exporting Preparations Do you export more than 1 ton of a substance in a preparation (1) annually to EU? (Check ingredients with manufacturer) Is the preparation manufacturer willing to register the substance? (Check with manufacturer) Can you procure from another source willing to register, or procure locally in EU? START Do you export more than 1 ton of a preparation annually to EU? Preparation manufacturer pre- registers and registers substance through only representative (provision of export quantities to EU members and other data, and confirmation of pre-registration (2) and registration (3) required) Consider procuring from another source Consider pre-registering and registering yourself (importer or only representative) No Yes No Yes (1)The need for compliance depends not on the export quantity of the preparation itself but on the export quantity of substances in the preparation. (2)Deadline for pre-registration is Dec. 1, 2008. (3)Pre-registration extends the deadline for registration. The initial registration deadline is Dec. 1, 2010. This flow chart was created to provide vendors manufacturing or selling outside the EU region with a simple way of determining their need to comply with the REACH regulation. If the possibility of such a need is indicated, be sure to check the text of the regulation itself when studying how to comply. No action required

5 Flow Chart 3 Vendors Exporting Articles START Does the article contain a substance intended to be released, (1) and is more than 1 ton of the substance exported to EU annually? No Yes Does an article for export to EU contain restricted substances (2) ? Does an article for export to EU contain >0.1%w/w of an authorization candidate substance (SVHC) (3) ? Do you export more than 1 ton of the SVHC annually to EU? Consider registering, etc. as per Flow Chart 2 Check content of substance in each article for export to EU Provide information to importer and comply with consumer requests (4) Notification (5) must be made by importer or only representative No further action Check restrictions and consider use of alternative substance, etc. Yes No (1) Construction equipment includes window washer fluid, fire extinguishers, volatile corrosion inhibitors, etc. (2) A substance listed in REACH Annex XVII. (3) Not yet announced as of Sept. 2008; 16 substances now under deliberation. (4) On request from a consumer, information must be provided within 45 days. (5) Notification becomes obligatory June 1, 2011. This flow chart was created to provide vendors manufacturing or selling outside the EU region with a simple way of determining their need to comply with the REACH regulation. If the possibility of such a need is indicated, be sure to check the text of the regulation itself when studying how to comply.

6 2. Registration and Pre- registration For the following substances, if the total amount of a chemical substance exported to the EU exceeds 1t/year, registration is required. (1) Substances in a preparation (2) Substances intended to be released from an article *The amount of a substance is the total for one substance per vendor. *Pre-registering allows vendors a grace period before actual registration. Items needed for registrationItems needed for pre-registration (a)Name and address of manufacturer (importer) (b)Substance name, quantity range (e.g., 1 to 10t) (c)Purpose for use (d)Toxicity and safe use information (e)Results of risk and toxicity assessment (a)Name and address of manufacturer (importer) (b)Substance name, quantity range (e.g., 1 to 10t) (c)Planned year of registration

7 3. Examples of Preparations Handled by Construction Equipment Manufacturers The following products are considered as “preparations” when exported as supplies, separate from equipment. Extinguishing agent in fire extinguisher Window washer fluid Grease Lubricating oil or other lubricant Anti-corrosion oil Paint Adhesive Refrigerant Liquid gasket Caulking agent

8 4. Examples of “Substances Intended to be Released from an Article” Handled by Construction Equipment Manufacturers The following products constitute “substances intended to be released from an article.” When loaded in equipment for export: Extinguishing agent in fire extinguisher Window washer fluid When packaged with part for export: Oil for volatile corrosion inhibitor paper (bag) 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 chemical composition (REACH Article 3.3) Intended to be released: Intentional release from an article under normal or reasonably foreseeable conditions of use. As with material released from a tire due to friction, for example, secondary release from an article while it is functioning should be considered as intended release.

9 Chemical substance A in a preparation EU Shovel Importer EU Chemical Agency Register Export EU Japan Shovel 5-1. Who Registers and Who Can Register Registration is made with the EU Chemical Agency by the manufacturer or importer of a preparation or article. However, only corporate entities in the EU can register. Entities outside the EU can name an Only Representative in the EU, who will register on their behalf. Chemical substance A in a preparation EU Shovel Importer EU Chemical Agency Register Export EU Japan Shovel EU O.R. Register ↑Either/Or↓ Only representative Designate

10 Chemical substance A in an article EU Shovel Importer EU Chemical Agency Register Export EU Japan Shovel 5-2. Who Registers and Who Can Register Note that a “substance intended to be released from an article” does not have to be registered if it has already been registered for the same use. That is, so long as someone (supplier, competitor, etc.) has registered it, it’s OK. Chemical substance A in an article EU Shovel Importer EU Chemical Agency Register Export EU Japan Shovel EU Chemical Register ↑Either/Or↓

11 6. Examples of Restricted Substances Handled by Construction Equipment Manufactures The following substances (see REACH Annex XVII) cannot be exported unless certain requirements are observed. Substance NameCAS No.Use Benzene71-43-2Fuel Asbestos fiber12001-28-4, 12172-73- 5, 77536-67-5, 77536- 66-4, 77536-68-6, 12001-29-5, 132207- 32-0 Polybrominated biphenyls 59536-65-1 Lead carbonate598-63-0, 1319-46-6 Lead sulfate7446-14-2, 15739-80-7 Mercury compoundsBattery cells, storage batteries Arsenic compounds Organic tin compounds Cadmium7440-43-9Paint, stabilizing agents, plating Toluene108-88-3Adhesives, spray paints Polycyclic aromatic hydrocarbons 50-32-8, 192-97-2, 56- 55-3, 218-01-9, 205-99- 2, 205-82-3, 207-08-9, 53-70-3 Tire extender oils

12 7. Obligations Regarding SVHC Export to the EU of machinery or parts containing >0.1% w/w of a substance of very high concern (SVHC) entails the obligation to provide information to consumers. - If there is a request from a consumer, a response with Information for safety use (At least, the names of substances) must be made within 45 days. Moreover, If the amount of a chemical substance exported to the EU exceeds a total of 1t/year, notification is required. Notification is not necessary, however, if the substance has already been registered for the same use.

13 Substance nameCAS No.Use Sodium dichromate dihydrate 7789-12-0Chromate processing after galvanizing; zinc powder coating (DACROTIZED® treatment) Triethyl arsenate15606-95-8Semiconductors Hexabromocyclododecane25637-99-4Bromine flame retardants Dibutyl phthalate84-74-2Plasticizers for plastic and rubber parts Diethylhexyl phthalate117-81-7 Benzyl butyl phthalate85-68-7 8. SVHC Among SVHC candidates so far, those substances contained in construction equipment and their uses are indicated below. The followings are decided as “substance of very high concern (SVHC)” sequentially in future. (1) CMR (2) PBT (3) vPvB

14 9. Schedule for REACH Enforcement 20086.1 to 12.1Pre-registration period 10 (end)Decision on 1st SVHC candidate list - Start of obligation to provide information to consumers 20091.1Pre-registration results announced 6.1Regulation of restricted substances starts 201012.1Deadline for registration of substances exceeding 1000t/year, CRM exceeding 1t/year, and R50/53 exceeding 100t/year 20116.1Notification of SVHC in articles starts 20136.1Deadline for registration of substances exceeding 100t/year 20186.1Deadline for registration of substances exceeding 1t/year

15 References REACH Regulation (EC) No.1907/2006 and Directive 2006/121/EC amending Council Directive 67/548/EEC http://europa.eu.int/eur- lex/lex/JOHtml.do?uri=OJ:L:2007:136:SOM:EN:HTML ECHA (European Chemicals Agency) http://reach.jrc.it/guidance_en.htm IUCLID 5 (International Uniform Chemical Information Database) http://ecbwbiu5.jrc.it/ Ministry of the Environment (Japan) http://www.env.go.jp/chemi/reach/reach.htmlhttp://www.env.go.jp/chemi/reach/reach.html (in Japanese) Ministry of Economy, Trade and Industry (Japan) http://www.meti.go.jp/policy/chemical_management/int/reach.html (in Japanese) Japan Auto Parts Industries Association (Japanese translation of “Automotive Industry Guideline on REACH (AIG)”) http://www.japia.or.jp/whatnew/2008/05/_919.html Japan Environmental Management Association for Industry (seminars, consulting, registration services, etc.) http://www.crs.jemai.jp/crs_c_1_4.htmlhttp://www.crs.jemai.jp/crs_c_1_4.html (in Japanese)

16 Japan Construction Equipment Manufacturers Association REACH Compliance Project Team Leader Yoshie Ideura (Komatsu Ltd.) Board Kiyoshi Noritake (IHI Construction Machinery Ltd.) Board Norikazu Okabe (Aichi Corporation) Board Hideki Nagatani (Kawasaki Heavy Industries, Ltd.) Board Takao Oshio (Caterpillar Japan Ltd.) Board Kazuyuki Saki (Kobelco Construction Machinery Co., Ltd.) Board Masahiro Tokita (Sakai Heavy Industries, Ltd.) Board Takehisa Ishikura (Sumitomo Construction Machinery Co., Ltd.) Board Yoshihiro Hoshino (Hitachi Construction Machinery Co., Ltd.) Board Hajime Setoguchi (Yanmar Construction Equipment Co., Ltd.) Secretariat Kazushige Okamoto (Japan Construction Equipment Manufacturers Association)


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