Guideline for

REACHRegistration, Evaluation, Authorization and

Restriction of Chemicals

Regulation (EC) No.1907/2006

Guideline for

REACHRegistration, 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

[Table of Contents]

1. Simplified Flow Charts of REACH Regulation Compliance2. Registration and Pre-registration 3. Examples of Preparations Handled by Construction Equipment Manufacturers4. Examples of “Substances Intended to be Released from an Article” Handled by Construction Equipment Manufacturers5. Who Registers and Who Can Register 6. Examples of Restricted Substances Handled by Construction Equipment Manufactures 7. Obligations Regarding SVHC8. 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.

Flow Chart 1Confirming 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

Preparation Article

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.

Flow Chart 2Vendors Exporting Preparations

Do youexport more than 1 ton

of a substance in a preparation(1) annually to EU? (Check

ingredients with manufacturer)

Is the preparationmanufacturer 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

No

No

Yes

Yes

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

No action required

Flow Chart 3Vendors 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 anauthorization candidate

substance (SVHC)(3)?

Do youexport 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 representativeNo further action

Check restrictions and consider use of alternative substance, etc.

Yes

Yes

Yes

No

No

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.

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 registration Items 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

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

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.

Chemical substance

A in apreparation

EU Shovel

Importer

EUChemical

Agency

Register

Export

EUJapan 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 apreparation

EU Shovel

Importer EUChemical

AgencyRegister

Export

EU

Japan Shovel

EU O.R.

Register

↑Either/Or↓

Only representative

Designate

Chemical substance

A in anarticle

EU Shovel

Importer

EUChemical Agency

Register

Export

EUJapan 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 anarticle

EU Shovel

Importer EUChemical

AgencyRegister

Export

EU

Japan Shovel

EU Chemical

Register

↑Either/Or↓

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 Name CAS No. Use

Benzene 71-43-2 Fuel

Asbestos fiber 12001-28-4, 12172-73-5, 77536-67-5, 77536-66-4, 77536-68-6, 12001-29-5, 132207-32-0

Polybrominated biphenyls

59536-65-1

Lead carbonate 598-63-0, 1319-46-6

Lead sulfate 7446-14-2, 15739-80-7

Mercury compounds Battery cells, storage batteries

Arsenic compounds

Organic tin compounds

Cadmium 7440-43-9 Paint, stabilizing agents, plating

Toluene 108-88-3 Adhesives, 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

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.

Substance name CAS No. Use

Sodium dichromate dihydrate

7789-12-0 Chromate processing after galvanizing; zinc powder coating (DACROTIZED® treatment)

Triethyl arsenate 15606-95-8 Semiconductors

Hexabromocyclododecane 25637-99-4 Bromine flame retardants

Dibutyl phthalate 84-74-2 Plasticizers for plastic and rubber parts

Diethylhexyl phthalate 117-81-7

Benzyl butyl phthalate 85-68-7

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

9. Schedule for REACH Enforcement

2008 6.1 to 12.1 Pre-registration period

10 (end) Decision on 1st SVHC candidate list

－ Start of obligation to provide information to consumers

2009 1.1 Pre-registration results announced

6.1 Regulation of restricted substances starts

2010 12.1 Deadline for registration of substances exceeding 1000t/year, CRM exceeding 1t/year, and R50/53 exceeding 100t/year

2011 6.1 Notification of SVHC in articles starts

2013 6.1 Deadline for registration of substances exceeding 100t/year

2018 6.1 Deadline for registration of substances exceeding 1t/year

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.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.html (in Japanese)

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)