1 REACH 10 th July 2008 Kwidzyn Poland “Business Support Programme for Bulgaria, Romania, Croatia and Turkey” BSP 2007/

REACH training, 10/07/08, Kwidzyn PL 2  History background  definitions  ECHA  Preregistration vs registration  exemptions Presentation outline

REACH training, 10/07/08, Kwidzyn PL 3 background  2002 Johannesbourg meeting  Many regulations about chemical compounds over 40 regulations  Idea to unify the chemical market

REACH training, 10/07/08, Kwidzyn PL 4 Registration Evaluation Authorisation and Restriction of CHemicals Regulation (EC) No 1907/2006

REACH training, 10/07/08, Kwidzyn PL 5 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

REACH training, 10/07/08, Kwidzyn PL 6 Definitions Selected definitions:  Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

REACH training, 10/07/08, Kwidzyn PL 7  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

REACH training, 10/07/08, Kwidzyn PL 8  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;

REACH training, 10/07/08, Kwidzyn PL 9  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

REACH training, 10/07/08, Kwidzyn PL 10 Who is concerned  Producers/ Manufactures  Importers  End users

REACH training, 10/07/08, Kwidzyn PL 11 What substances are covered  Cancerogenic  Mutagenic  Reproductive toxicity  PBT  vPvB …… CMR

REACH training, 10/07/08, Kwidzyn PL 12 SDS Safety Data Sheet

REACH training, 10/07/08, Kwidzyn PL 13 SDS headings 1.identification of the substance/preparation and of the company/undertaking 2.hazards identification 3.composition/information on ingredients 4.first-aid measures 5.fire-fighting measures 6.accidental release measures 7.handling and storage 8.exposure controls/personal protection 9.physical and chemical properties

REACH training, 10/07/08, Kwidzyn PL stability and reactivity 11.toxicological information 12.ecological information 13.disposal considerations 14.transport information 15.regulatory information 16.other information SDS headings Example of the SDS

REACH training, 10/07/08, Kwidzyn PL 15 ECHA European CHemical Agency

REACH training, 10/07/08, Kwidzyn PL 16

REACH training, 10/07/08, Kwidzyn PL 17 About ECHA  Based in Helsinki, Finland  Resposible for: database Registration Examination Providing help Providing information about all ready registered/planed compounds

REACH training, 10/07/08, Kwidzyn PL 18 About 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.

REACH training, 10/07/08, Kwidzyn PL 19 Preregistration vs registration compounds have to preregistered till 1 st December 2008 Registration deadlines  30 Nov 2010  31 May 2013  31 May 2018

REACH training, 10/07/08, Kwidzyn PL 20 Timeline for registration Source: legislastion leaflet

REACH training, 10/07/08, Kwidzyn PL 21 Website Registration through website REACH-IT portal

REACH training, 10/07/08, Kwidzyn PL 22 What you need to do before submitting your 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.

REACH training, 10/07/08, Kwidzyn PL 23 What you need to do before submitting your inquiry to ECHA  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.

REACH training, 10/07/08, Kwidzyn PL 24 What you need to do before submitting your inquiry to ECHA  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”

REACH training, 10/07/08, Kwidzyn PL 25 What you need to do before submitting your inquiry to ECHA  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.

REACH training, 10/07/08, Kwidzyn PL 26 registration First registration period till 2010 Main concern: most dangerous high volume

REACH training, 10/07/08, Kwidzyn PL 27 Information 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 More then 1000

REACH training, 10/07/08, Kwidzyn PL 28 Information for registration  Name and contact information (of a Contact person or Third party Representative who will act as the contact point in data sharing)

REACH training, 10/07/08, Kwidzyn PL 29 Registration 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.

REACH training, 10/07/08, Kwidzyn PL 30 Third Party Representative  Cost sharing  „Hide” some information from competitors  Take care of commercial secrets

REACH training, 10/07/08, Kwidzyn PL 31 Joint 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

REACH training, 10/07/08, Kwidzyn PL 32 Benefits from preregistration  More time!  Allow the business to run

REACH training, 10/07/08, Kwidzyn PL 33  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 preregistration

REACH training, 10/07/08, Kwidzyn PL 34 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

REACH training, 10/07/08, Kwidzyn PL 35 Database from ECHA After 1 Jan 2008  List of preregistered substances will be published (website) Name Identity codes (CAS, EINECS,..) Registration deadline

REACH training, 10/07/08, Kwidzyn PL 36  Only if you import or produce for the first time First time counts from entering law into force 1 June 2007 Benefits from preregistration after 1 Dec 2008

REACH training, 10/07/08, Kwidzyn PL 37 exemptions  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

REACH training, 10/07/08, Kwidzyn PL 38  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 exemptions

REACH training, 10/07/08, Kwidzyn PL 39 exemptions  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

REACH training, 10/07/08, Kwidzyn PL 40 exemptions  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

REACH training, 10/07/08, Kwidzyn PL 41 exemptions  Excluded from need of registration are substances that transit through EU

REACH training, 10/07/08, Kwidzyn PL 42 Case Import goods (eg. Paint, galvanic chemistry, fire retardant) from outside EU -will the supplier register those goods

REACH training, 10/07/08, Kwidzyn PL 43 Useful links  REACH Regulation EC No 1907/  ECHA website:  REACH-IT:  REACH Guidance Documents