1 REACH 10 th July 2008 Kwidzyn Poland “Business Support Programme for Bulgaria, Romania, Croatia...

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REACHREACH

10th July 2008Kwidzyn Poland

““Business Support Programme for Bulgaria, Romania, Croatia and TurkeyBusiness Support Programme for Bulgaria, Romania, Croatia and Turkey””

BSP 2007/142-722

REACH training, 10/07/08, Kwidzyn PL 2

History background definitions ECHA Preregistration vs registration exemptions

Presentation outlinePresentation outline


backgroundbackground

2002 Johannesbourg meeting

Many regulations about chemical compounds over 40 regulations

Idea to unify the chemical market


RegistrationEvaluationAuthorisation and Restriction ofCHemicals

Regulation (EC) No 1907/2006


This Regulation replaces: Directive 76/769/EEC, Commission Directive 91/155/EEC, Commission Directive 93/67/EEC, Commission Directive 93/105/EC, Commission Directive 2000/21/EC, Regulation (EEC) No 793/93 Commission Regulation (EC) No 1488/94


DefinitionsDefinitions

Selected definitions: Substance: means a chemical element and its

compounds in the natural state or obtained byany manufacturing process, including any additive necessary to preserve its stability andany impurity deriving from the process used, but excluding any solvent which may beseparated without affecting the stability of the substance or changing its composition;


Preparation: means a mixture or solution composed of two or more substances

Article: means 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

Producer of an article: means any natural or legal person who makes or assembles an article within the Community

Registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance


Manufacturing: means production or extraction of substances in the natural state;

Manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community;

Import: means the physical introduction into the customs territory of the Community;

Importer: means any natural or legal person established within the Community who is responsible for import;


Placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market


Who is concernWho is concerneded

Producers/ Manufactures

Importers

End users


What substances are coveredWhat substances are covered

Cancerogenic Mutagenic Reproductive toxicity

PBT vPvB

…

CMR


SDSSDS

SafetyDataSheet


SDS SDS headingsheadings

1. identification of the substance/preparation and of the company/undertaking

2. hazards identification3. composition/information on ingredients4. first-aid measures5. fire-fighting measures6. accidental release measures7. handling and storage8. exposure controls/personal protection9. physical and chemical properties


10.stability and reactivity11.toxicological information12.ecological information13.disposal considerations14.transport information15.regulatory information16.other information

SDS SDS headingsheadings

Example of the SDS


ECHAECHA

EuropeanCHemicalAgency


http://echa.europa.eu


About ECHAAbout ECHA

Based in Helsinki, Finland Resposible for:

database Registration Examination Providing help Providing information about all ready registered/planed

compounds


About ECHAAbout ECHA

The Agency should be financed partly by fees paid by natural or legal persons and partly by the general budget of the European Communities.


Preregistration vs registrationPreregistration vs registration

compounds have to preregistered till 1st December 2008

Registration deadlines 30 Nov 2010 31 May 2013 31 May 2018


Timeline for registrationTimeline for registration

Source: legislastion leaflet


Website Website Registration through websiteREACH-IT portal

http://echa.europa.eu/reachit_en.asp


What you need to do before submitting What you need to do before submitting your inquiry to ECHAyour inquiry to ECHA

Account creation: As a potential registrant you must sign-up in REACH-IT as explained on the account creation page of this web section. It will not be possible to send the inquiry if you do not have a REACH-IT account and a UUID for your company.



Inquiry information requirements form: The form can be accessed via the further information heading below. You must complete the form online, download it and save it in suitable place. The completed form must then be attached to section 13 of your IUCLID 5 substance dataset during preparation of your inquiry dossier.



Preparation of inquiry dossier: You must prepare your inquiry dossier in IUCLID 5 following the guidance in the “Manual on how to prepare an inquiry dossier in IUCLID 5 and its submission to ECHA”. Be sure to attach the “inquiry information requirements form”



Submission form: You must download the form and complete it with the required information which must match the information you used to create your company account in REACH-IT.


registrationregistration

First registration period till 2010

Main concern: most dangeroushigh volume


Information for registrationInformation for registration

Substance Identity: EINECS number CAS numbers names of the substance (IUPAC, common, other)

Envisaged deadline and tonnage band for the registration 1-10 tonnes per year 10-100 100-1000 More then 1000


Information for registrationInformation for registration

Name and contact information (of a Contact person or Third party Representative who will act as the contact point in data sharing)


Registration abroad EURegistration abroad EU

Companies that manufacture substances, formulate preparations or produce articles outside the EU cannot (pre-)register substances. However, they can nominate an Only Representative established within the EU to carry out the required (pre-) registration of their substances that are imported into the EU.


Third Party RepresentativeThird Party Representative

Cost sharing „Hide” some information from competitors Take care of commercial secrets


Joint registrationJoint registration

Joint submission of data by multiple registrants

When a substance manufactured or imported by more than one company, they are required to submit certain information together


Benefits from preregistrationBenefits from preregistration

More time!

Allow the business to run


Pre-registration is free of charge, but…!

„producer” part of a Substance Information Exchange Forum (SIEF) until 1 June 2018 and may need to actively participate to the SIEF activities. In addition you may have financial obligations in relation to your substance.

Benefits from preregistrationBenefits from preregistration


Did not register on time?Did not register on time?

After December 2008 will have to submit a registration dossier for that

substance before you can continue manufacturing or importing it in 1 tonne or more per year after 2008

Have to wait for registration number from ECHA

determine whether a registration or an inquiry was previously submitted for the same substance

Obtain and assess relevant physico-chemical, health and environmental data and use information in order to compile your registration dossier

Submit the dossier and pay the related fee


Database from ECHADatabase from ECHA

After 1 Jan 2008 List of preregistered substances will be

published (website) Name Identity codes (CAS, EINECS,..) Registration deadline


Only if you import or produce for the first time

First time counts from entering law into force 1 June 2007

Benefits from preregistrationBenefits from preregistration after 1 Dec 2008 after 1 Dec 2008


exemptionsexemptions

medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC

cosmetic products as defined in Directive 76/768/EEC

medical devices which are invasive or used in direct physical contact with the human body Directive 1999/45/EC

food or feeding in accordance with Regulation (EC) No 178/2002


food or feeding as a food additive in foodstuffs within the scope

of Directive 89/107/EEC; as a flavouring in foodstuffs within the scope of

Directive 88/388/EEC and Decision 1999/217/EC; as an additive in feedingstuffs within the scope of

Regulation (EC) No 1831/2003; in animal nutrition within the scope of Directive

82/471/EEC




Natural resources (minerals, ores, crude oil, gas, coke not modified)

Common elements of which hazards are well known (oxygen, hydrogen, nobel gases, nitrogen)

polymers

exemption from the obligation to register are listed in Annex IV



Incidental reaction with air, moisture, mircorbiogical sunlight

Substances occuring during end use (not intented for sell)

Natural substances (occur in nature not modified)

By-products



Excluded from need of registration are substances that transit through EU


CaseCase

Import goods (eg. Paint, galvanic chemistry, fire retardant) from outside EU

-will the supplier register those goods


Useful linksUseful links

REACH Regulation EC No 1907/2006http://eur-lex.europa.eu/JOHtml

.do?uri=OJ:L:2007:136:SOM:EN:HTML

ECHA website: http://echa.europa.eu

REACH-IT: http://echa.europa.eu/reachit

REACH Guidance Documentshttp://reach.jrc.it/guidance_en.htm

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