REGULATORY SERVICES - writing SDS - REACH - Biocides - Cosmetics - Detergents

Service FDS

PLEASE NOTE: Since December 2012 the latest format for appendix 2 of REACH is required for all SDSs for mixtures

Application of the GHS/CLP since December 2010 for pure substances
Required for all mixtures in June 2015
 

Writing SDSs

We write Safety Data Sheets in all languages for all types of products. SDSs are drawn up rapidly from data provided (composition) by toxicological regulations experts and chemists. SDSs are finalised in the GSH/CLP for substances and according to the request in the Directive (1999/45/EC) for mixtures. We take care of any need for laboratory tests. List of standard physico-chemical tests and measurements:

  • FLASH POINT measurement
  • BOILING POINT measurement
  • VAPOUR PRESSURE measurement
  • Inferior and superior EXPLOSIVE LIMIT measurement
  • SPONTANEOUS IGNITION TEMPERATURE measurement
  • VISCOSITY measurement
  • DENSITY measurement
  • MELTING TEMPERATURE measurement
  • In Vitro CORROSIVENESS test, IRRITATION test, etc...

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Biocides Directive N° 98/8/EC

  • Verifying or writing the SDS
  • Biocides labelling
  • Registration
  • MA - Marketing Authorisation
  • Efficacy tests
  • Preparing dossiers

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REACH

Topics
  • Which substances should be registered?
  • How to notify the ECHA of a substance?
  • What is a substance according to REACH?
  • How to use the IUCLID5?
  • Who are the other declarants?
  • How to share the data?

DO NOT FORGET TO NOTIFY THE ECHA OF IMPORTED SUBSTANCES AND THOSE MANUFACTURED OUTSIDE OF EUROPE AT THE CLASSIFICATION AND LABELLING INVENTORY

List of documents to download::
 - 1999/45/EC Consolidated Text : calculation of the classification of mixtures in the pre-existing regulations
 - New Annex 2 of Reach on the SDS formats
 - CLP 1272/08

REACH WAS ADOPTED AND HAS BEEN EFFECTIVE SINCE 1 JUNE 2007

 The European Parliament's vote on 13 December 2006 and the adoption by the Council on 18 December establish the adoption of REACH and finally enable the completion of the text.

The various compromises accepted on 13 December are the following:

Authorisations:
    The principle of final substitution is definitely set as an objective. Apart from the rules[1] concerning the possibility to obtain authorisation according to the category of substance to be used (CMR 1 or 2, Endocrine disrupter or PBT, vPvB), a substitution plan will be required if there are appropriate alternatives or if not, if research and development studies are planned.
    The system for authorisation of endocrine disrupters will be revised 6 years after the effective date of REACH. In fact, as is the case for persistent and bioaccumulative substances (PBT and vPvB), the wish is for endocrine disrupters to be authorised only if there is no appropriate substitution and if the socio-economic advantages are demonstrated.
    Nanoparticles (which are included in the REACH scope) are not specifically integrated as such in the authorisation system, even though this was requested through an amendment project.

 Registrations:
    The "Chemical Safety Report"
is not required for the 1 - 10 tons tonnage band but this possibility will be re-examined 7 years after the effective date of REACH.
    The registration deadline for the Q> 1,000 tons tonnage band was extended (3½ years instead of the 3 years that were initially scheduled).
    The period for data protection has increased from 10 years to 12 years.

Methods concerning the toxicity for reproduction:
    A revision of the requirements for tests concerned in section 8.7 of appendix VIII (toxicity for reproduction) is scheduled 12 years after the effective date of REACH.

 Calendar of the main actions for registration:
It is becoming urgent for companies to carry out the inventories of their substances in order to prepare for the next deadlines:
     · Deadline limits for registrations of phase-in substances:
                o 1 December 2010: Q >1,000 tons, CMR (1 or 2) Q > 1 ton, R50/53 Q > 100 tons.
                o 1 June 2013: Q > 100 tons
                o 1 June 2018: Q > 1 ton.

 NOTE: NOTIFYING THE ECHA OF IMPORTED SUBSTANCES AND MANUFACTURED SUBSTANCES ALREADY ON THE MARKET (EVEN < 1t)

 [1] Either the risk is controlled (involves the existence of a valid exposure limit) for CMR 1 or 2, or Endocrine Disrupters, or the socio-economic advantages have been demonstrated AND there is no appropriate substitution for the PBTs and vPvB or CMR 1 or 2 (no valid limit available) or Endocrine Disrupters (no valid limit available).


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COSMETICS DOSSIERS

Our cosmetics regulations expert will take responsibility of the complete preparation of the file. Our expertise in toxicology and our knowledge of the regulations concerning chemical products is our primary advantage.

  • European Pharmacopoeia challenge test
  • 48-hour patch test
  • Eye irritation
  • Packaging validation
  • Calculation of the PAO
  • Evaluation of the product safety
  • CPND notification

Do not wait. Find out more now.

Further information
The scientific quality of the expert toxicological evaluation prior to the registration of a substance is essential. In collaboration with university and private laboratories, ITekem conducts bibliographic research and completes expert reports on the evaluation of the physico-chemical, toxicological and eco-toxicological characteristics of substances subject to registration. In this framework, ITekem ensures the preparation of QSARs that complete the reports and if they confirm the preliminary study, make it possible to avoid costly experimental tests. ITekem can assume the responsibility for all or a part of the procedures for finalising the registration of a substance.


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