REACH

Substances due for REACH registration in 2010

- LEAD Only Rep. (SSS)

REACH- 2010 Substance Details of SSS > 1000 TPA (tons per annum) - 100 100 – 1000 TPA (R50/53 & CMR – 1/2) - 41 1-100 TPA (CMR category 1/2 )– 70Total 211Intent to register - 106Lead registrant (LR) identified – 69No LR identified - 37Consortia existing – 41No LR, No SFF - 6

2010 substances divided into various groups

Monomers (27) Petroleum Distillates (19) Others (Including TII & natural substances

(11) Organic (97) Inorganic (49) Dyes/Pigments (12)

Petroleum Distillates (Applicability of notes)Total such substances of SSS in 2010 deadline – 19Deadline shifted (based upon Notes) 5 Results awaited- 14Various Notes N: Substance is not a carcinogen if the full refining history is

known and it can be shown that the substance from which it is produced is not a carcinogen.

L: DMSO extract (measured by IP 346 method) is less than 3.0% P: substance contains less than 0.1 % w/w benzene (EINECS No

200-753-7)

CONT....

Benefits: If notes are applicable, then the deadline will shift to a later deadlineEssential requirement: Valid test results according to suggested method within REACH Another case of interest

C.I. Basic Violet 3 with >0.1% of Michler’s Ketone (EC No 202-027-5)

Transported Isolated Intermediates (TII)

Definition: (about 10)A substance that is put to further chemical processing in Europe and in the chemical reaction that takes place, the transported intermediate completely loses its chemical identity (trace levels of unreacted intermediate may remain)Benefits Minimal information requirements if tonnage is < 1000 tpa Information requirements of only Annex VII apply if tonnage is > 1000 tpa

Essential criteria to be fulfilled to avail benefit

All European buyers that use the TII should give an undertaking that they put the TII to further chemical processing fulfilling all the controlled conditions as mentioned in the REACH regulation

Monomers & Polymer Issue

Polymers are exempted within REACH but the monomers have to comply to REACHAccording to Article 6(3), the manufacturer or importer of a polymer must however submit a registration to the Agency for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met: (a) the polymer consists of 2% weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s); (b) the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year (the total quantity of monomer or other substance ending up in the final polymer unbound or chemically bound to the polymer)

Exemption for Natural Substances

In this case, exemption applies to the following if not chemically modified

Minerals, ores, ore concentrates, raw and processed natural gas, crude oil, coal

Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts

In addition, certain chemical substances as listed in Annex IV of the REACH regulation are also exempt from REACH registration as these are considered to cause minimum risk because of their intrinsic properties

Services covered by the OR Maintaining legal status in EU as OR (need OR Agreement in addition to active REACH IT accounts)

SIEF representation and communication with LR/SFF/Consortium secy/other

SIEF participants (constantly checking SIEF/consortia status, responding REACH IT emails…)- doesn’t include cost of physical meeting which will involve manday cost, travel and stay

Providing general consultancy in co-ordination with customers to decide next steps (sending DU templates for sending OR appointment confirmation to customers, meetings, general queries)

Tonnage band change (wherever required)

Answering to enforcement agencies

Legal fee and insurance fee and managing residual legal liabilities Documentation and communication of SIEF codes to appropriate parties

Maintaining compliances related documentation

Updating about changes in relevant regulatory framework and acting accordingly

Data maintenance (customer specific record – technical data/tonnage info/DU info/Uses/substance sameness/LAPD codes/SIEF-LR agreement/consortium agreement/invoice & payment confirmation)

Services NOT covered by the OR

This includes:All actual cost payable to third parties like (ECHA/LR/data holders/outside consultants) – these costs should be paid well in advance

Detailed legal advice on SIEF/LR/Consortia agreement

Fees for IUCLID dossier preparation and submission to ECHA using REACH IT in 2010/2013/2018

Preparation of CSA/CSR

Fees for Downstream users Communication - Collection of Use related information using online portal. To be decided jointly with council

Importance of Tonnage Band

Tonnage band very important in deciding deadline Tonnage needs to calculated from June 2007 to Dec 2007 (for calendar year 2007)

Thereafter it will be Jan to Dec’ 2008 & 2009

However, if the tonnage of > 1000 tpa has been exceeded even once, the deadline will be 30th Nov’ 2010

E.g. If the tonnage exported to Europe is as mentioned below:

Period Annual tonnage exported

Jan to Dec 2007 1200

Jan to Dec 2008 800

Jan to Dec 2009 700

However, if after subtracting Jan to May’ 2007 tonnage, the tonnage comes out to be 800 or 900 tons then the 2010 deadline can be avoided, as neither the average tonnage has not exceed 1000 nor calendar year tonnage

Therefore calculate tonnage band extremely carefully

Data availability & Use Profile

Data Availability

67 subs (28 companies) out of total 216 substances

Use profile

Indian Companies: 60 subs (27 companies)

EU buyers: 20 subs (15 companies)

% of data availability – 31%

% of use profile (Indian companies) – 27%

% of use profile (EU buyers) – 9%Very low % data availability & Use profile provided by the companies – These details need to be furnished by the companies to SSS on priority

Substance Sameness RequirementsSpectral data

1. Ultraviolet and Visible Absorption Spectroscopy (UV/VIS)

2. Infrared Spectroscopy (IR)

3. Nuclear Magnetic Resonance Spectroscopy (NMR) or Mass spectroscopy (MS)

3 type of spectra’s mandatory

Chromatograms

1. Gas Chromatography (GC) or

2. High-Performance Liquid Chromatography (HPLC)

Any 1 chromatogram mandatory

For inorganic substances

1. X-Ray Diffraction (XRD) or

2. X-Ray Fluorescence (XRF) or

3. Atomic Absorption Spectroscopy (AAS) Any one mandatory

Substance Sameness Requirements (Contd)

Substance name ( CAS Name)

IUPAC Name

CAS No.

EC No (EINECS No)

Molecular formula

Molecular weight / Molecular weight range

Structural formula (Image)

Compositional details (purity of the substance)

Impurity details: Name of Impurity % of Impurity CAS no. EC No. Molecular Formula Molecular weight Structure

Additives details: Name of Impurity % of Impurity CAS no. EC No. Molecular Formula Molecular weight Structure

MSDS Essentials

16 point MSDS Mandatory

Hazards identification should precede compositional information (as per the REACH format)

Substances or Preparations for which a SDS is required: The substance on its own or in preparation meets the criteria for classification as

dangerous under Directive 67/548/EEC or Directive 1999/45/EC, or It is PBT or vPvB substance, or It is included in the candidate list of substances which may be subjected to

authorization.

SDS is required at the request of a recipient At least one substance posing human health or environmental hazards in an

individual concentration of 1% by weight for non-gaseous preparations and 0.2% by volume for gaseous preparations; or

At least one SVHC in an individual concentration of 0.1% by weight for non-gaseous preparations; or

A substance for which there are community workplace exposure limits

REACH registration costs (per substance) Approximate

Subs Tonnage ECHA Registration Fee

Data Cost (LoA)

OR Annual Fee

Total in EurosApprox

>1000 tpa 23,250 10,000 400 33,650

100 – 1000 tpaR 50/53

8,625 7,500 400 16,525

10-100 tpaCMR 1 & 2

3,225 5,000 400 8,625

1 -10 tpaCMR 1 & 2

1,200 3,000 400 4,600

Considering large company & joint submission

REACH registration costs (per substance)

Subs Tonnage ECHA Registration Fee

Data Cost (LoA)

OR Annual Fee

Total in EurosApprox

>1000 tpa 16,275 10,000 400 26,675

100 – 1000 tpaR 50/53

6,038 7,500 400 13,938

10-100 tpaCMR 1 & 2

2,258 5,000 400 7,658

1 -10 tpaCMR 1 & 2

840 3,000 400 4,240

Considering medium company & joint submission

REACH registration costs (per substance)

Subs Tonnage ECHA Registration Fee

Data Cost (LoA)

OR Annual Fee

Total in EurosApprox

>1000 tpa 9,300 10,000 400 19,700

100 – 1000 tpaR 50/53

3,450 7,500 400 11,350

10-100 tpaCMR 1 & 2

1,290 5,000 400 6,690

1 -10 tpaCMR 1 & 2

480 3,000 400 3,880

Considering small company & joint submission

REACH registration costs (per substance)

Subs Tonnage ECHA Registration Fee

Data Cost (LoA)

OR Annual Fee

Total in EurosApprox

>1000 tpa 2,325 10,000 400 12,725

100 – 1000 tpaR 50/53

863 7,500 400 8,763

10-100 tpaCMR 1 & 2

323 5,000 400 5,723

1 -10 tpaCMR 1 & 2

120 3,000 400 3,520

Considering micro company & joint submission