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Guideline for REACH Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (EC) No.1907/2006 PowerPoint Presentation
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Guideline for REACH Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (EC) No.1907/2006. No data, No market!. ★ As of June 2008, registration or notification is required for all chemical substances sold in the EU.

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slide1

Guideline forREACH

Registration, Evaluation, Authorization and Restriction of Chemicals

Regulation(EC) No.1907/2006

No data,

No market!

★As of June 2008, registration or notification is required for all chemical substances sold in the EU.

Japan Construction Equipment Manufacturers Association

Ver.12008.10.8

slide2

[Table of Contents]1. Simplified Flow Charts of REACH Regulation Compliance2. Registration and Pre-registration3. 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 Register6. Examples of Restricted Substances Handled by Construction Equipment Manufactures 7. Obligations Regarding SVHC8.SVHC9. 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.

slide3

1. Simplified Flow Charts of REACH Regulation Compliance

Flow Chart 1

Confirming the need for REACHregulation compliance and product classifications

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.

START

Do you export to EU members a product(1) made or sold outside the EU region?

No

No action required

Yes

Is the exported product a ”preparation”(2) or an “article”(3)?

Preparation

Article

Go to Flow Chart 3 (Articles)

Go to Flow Chart 2

(Preparations)

  • Includes not only the machinery itself but also supplies provided with it such as service parts and hydraulic oil.
  • A mixture or solution of two or more substances. This applies to hydraulic oil, grease, paint, window washer fluid, etc., when exported separately.
  • The machinery itself, and also service parts, etc., that are exported.
slide4

Flow Chart 2

Vendors Exporting Preparations

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.

START

Do you export more than 1 ton of a preparation annually to EU?

No

No action required

Yes

Do youexport more than 1 ton of a substance in a preparation(1)annually to EU? (Check ingredients with

manufacturer)

No

No action required

Yes

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)

Is the preparationmanufacturer willing to register the substance? (Check with manufacturer)

Yes

No

Can you procure from another source willing to register, or procure locally in EU?

Yes

Consider procuring from another source

  • The need for compliance depends not on the export quantity of the preparationitself but on the export quantity of substances in the preparation.
  • Deadline for pre-registration is Dec. 1, 2008.
  • Pre-registration extends the deadline for registration. The initial registration deadline is Dec. 1, 2010.

No

Consider pre-registering and registering yourself (importer or only representative)

slide5

Flow Chart 3

Vendors Exporting Articles

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.

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?

Yes

Consider registering, etc. as per Flow Chart 2

No

Check content of substance in each article for export to EU

Does an article for export to EU contain restricted substances(2)?

Yes

Check restrictions and consider use of alternativesubstance, etc.

No

Does an article for export toEU contain >0.1%w/w of anauthorization candidate substance(SVHC)(3)?

Yes

Provide information to importer and comply with consumer requests(4)

No

Do youexport more than 1 ton of the SVHC annually to EU?

No

Yes

Notification(5) must be made by importer or only representative

No further action

(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.

2 registration and pre registration
2. Registration and Pre-registration

For the following substances,

if the total amount of a chemical substance exported to the EU exceeds 1t/year,

registrationis 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.

3 examples of preparations handled by construction equipment manufacturers
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
slide8

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 functioningshould be considered as intended release.

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)
5 1 who registers and who can register
5-1. Who Registers and Who Can Register

Registration is made with the EU Chemical Agencyby 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 Representativein the EU, who will register on their behalf.

EU

Japan Shovel

EU Shovel

Register

EUChemical Agency

Chemical substanceA in apreparation

Export

Importer

↑Either/Or↓

EU

EU Shovel

Japan Shovel

Register

EUChemical Agency

Export

Chemical substanceA in apreparation

Importer

Designate

EU O.R.

Register

Only representative

5 2 who registers and who can register
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.

Japan Shovel

EU

Chemical substanceA in anarticle

EU Shovel

Register

EUChemical Agency

Export

Importer

↑Either/Or↓

EU

EU Shovel

Japan Shovel

Register

EUChemical Agency

Export

Chemical substanceA in anarticle

Importer

EU Chemical

Register

6 examples of restricted substances handled by construction equipment manufactures
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.

7 obligations regarding svhc
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, notificationis required.

Notification is not necessary, however, if thesubstancehas already been registered for the same use.

slide13

8. SVHC

The followings are decided as “substance of very high concern (SVHC)” sequentially in future.

  • CMR
  • PBT
  • vPvB

Among SVHC candidates so far, those substances contained in construction equipment and their uses are indicated below.

references
References

REACHRegulation(EC) No.1907/2006 and Directive2006/121/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)

slide16
Japan Construction Equipment Manufacturers Association

REACHCompliance 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)