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Soluzioni IT                                                Newsletter
                                                                                       July 2010
                                                                                             Issue 2




An “hot” autumn for chemicals management ?

                                                           Editorial

                                                           Summer is here, but companies keeps
                                                           their attention high on forthcoming
                                                           deadlines      on    notification   and
                                                           registration of chemical substances.
                                                           Next months will be decisive in order to
                                                           finalize the needed procedures and to
                                                           defend the business.
                                                           Some other interesting topics such as
                                                           food flavourings and additives for use
                                                           in plastic food contact materials are
                                                           also treated in this Issue.
                                                           Good reading and… happy holidays !
The risk of leaving registration until the last
minute
                                                                                    Stefano Colicchia
Companies that submit registration dossiers early -
             st
before next 1 October - will get their Completeness
Check result within 3 weeks and will have the time to
resubmit.                                                  SVHC, 8 new substances
Should they fail the second time, they can even start      The European Chemicals Agency, has
the process again provided they are in a position to       added 8 chemical substances to the
                                st
make a new submission before 1 December.                   Candidate List of Substances of Very
However, those submitting late will have only one
                                                           High Concern (SVHC) for authorisation.
chance to get through the entire registration process      which now contains 38 substances in
successfully.                                              total.
This is because for dossiers arriving after 30             The 8 new substances, which are
September, ECHA examines the dossier on arrival,           carcinogenic, mutagenic or reprotoxic
and - if the dossier is not complete - writes to the       (CMR) substances, are:
                    st
registrant before 1 March 2011.
Companies then will get a reasonable deadline              •   Trichloroethylene
(typically a further four months) to provide the           •   Boric acid
information requested by ECHA.                             •   Disodium tetraborate, anhydrous
If that information is not provided satisfactorily, then   •   Tetraboron disodium heptaoxide,
the registration has failed and there is no second             hydrate
chance.                                                    •   Sodium chromate
The company does not receive a registration number         •   Potassium chromate
and the substance cannot legally be manufactured or        •   Ammonium dichromate
imported in the European Union. The manufacturing          •   Potassium dichromate
or import since the registration deadline will have
been illegal.
                                                           Read the full story on:
Submitting early will prevent companies being in this      http://echa.europa.eu/doc/press/pr_10_
uncertain situation which could be a risk to their         12_candidate_list_20100618.pdf
business.
ECHA has warmly recommended that companies do
not leave it until the last minute.
Our article on NCEC newsletter

The article “Firms could cut costs by
outsourcing regulatory compliance – the
evidence” was published on latest issue of UK
National Chemical Emergency Centre (NCEC)
newsletter
Read the full article on http://the-
ncec.com/may-2010 looking for chapter 3 “Cut
Costs by Outsourcing”

New requirements for SDS, amendment to
Annex II published

An amendment to the REACH Regulation's
provisions on Safety Data Sheets was published
in the Official Journal
New Regulation 453/2010/EC adapts the SDS          New SIN List database released
provisions in Annex II of REACH to Regulation
1272/2008 on harmonised classification,            ChemSec has announced a new user
packaging and labelling of substances and          interface for version 1.1 of their SIN
mixtures, the EU's GHS implementation.             (Substitute It Now) list with the aim to
                                                   help legislators, journalists, consumers,
The new MSDS provisions apply from 1               investors and manufacturers retrieve
December 2010.                                     information regarding the 356 high-
Full text can be downloaded from                   concern chemicals currently included on
                                                   the SIN List.
http://eur-
lex.europa.eu/JOHtml.do?uri=OJ:L:2010:133:SO       The database can be consulted at the
M:EN:HTML                                          following web address
                                                   http://www.sinlist.org/
Food flavourings, guidance on the data
needed for risk assessment published               Additives for use in plastic food
The European Food Safety Authority (EFSA)          contact   materials, updated   list
has published a guidance about the data            An updated version of the provisional list of
required for the evaluation of flavourings         additives for use in plastic food contact
                                                   materials and articles has been recently
Part A provides a proposal concerning the data
                                                   published by the European Commission.
required for the risk assessment of flavouring
substances, i.e. chemically defined substances     The list can be downloaded from :
with flavouring properties.
                                                   http://ec.europa.eu/food/food/chemicalsafety/f
Part B provides a proposal concerning the data
                                                   oodcontact/docs/080410_provisional_list_7_2
required for the risk assessment of categories     11009.pdf
of flavourings other than flavouring substances
for which an evaluation and an approval is
required according to Article 9 (b) – (f) of the
Regulation 1334/2008/EC on flavourings and
certain food ingredients with flavourings                                          Via F.lli Bandiera, 3
properties for use in and on foods                                              I-20020 Arconate (MI)
                                                                                                 ITALY
The document can be downloaded on
                                                                         Mobile : +39-346-740.3491
http://www.efsa.europa.eu/en/scdocs/scdoc/162                       info@compliance2business.eu
3.htm?WT.mc_id=EFSAHL01&emt=1




                                                   2 - compliance2business newsletter n° – July 2010
                                                                                        2

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Newsletter N.2 July 2010 (English)

  • 1. Soluzioni IT Newsletter July 2010 Issue 2 An “hot” autumn for chemicals management ? Editorial Summer is here, but companies keeps their attention high on forthcoming deadlines on notification and registration of chemical substances. Next months will be decisive in order to finalize the needed procedures and to defend the business. Some other interesting topics such as food flavourings and additives for use in plastic food contact materials are also treated in this Issue. Good reading and… happy holidays ! The risk of leaving registration until the last minute Stefano Colicchia Companies that submit registration dossiers early - st before next 1 October - will get their Completeness Check result within 3 weeks and will have the time to resubmit. SVHC, 8 new substances Should they fail the second time, they can even start The European Chemicals Agency, has the process again provided they are in a position to added 8 chemical substances to the st make a new submission before 1 December. Candidate List of Substances of Very However, those submitting late will have only one High Concern (SVHC) for authorisation. chance to get through the entire registration process which now contains 38 substances in successfully. total. This is because for dossiers arriving after 30 The 8 new substances, which are September, ECHA examines the dossier on arrival, carcinogenic, mutagenic or reprotoxic and - if the dossier is not complete - writes to the (CMR) substances, are: st registrant before 1 March 2011. Companies then will get a reasonable deadline • Trichloroethylene (typically a further four months) to provide the • Boric acid information requested by ECHA. • Disodium tetraborate, anhydrous If that information is not provided satisfactorily, then • Tetraboron disodium heptaoxide, the registration has failed and there is no second hydrate chance. • Sodium chromate The company does not receive a registration number • Potassium chromate and the substance cannot legally be manufactured or • Ammonium dichromate imported in the European Union. The manufacturing • Potassium dichromate or import since the registration deadline will have been illegal. Read the full story on: Submitting early will prevent companies being in this http://echa.europa.eu/doc/press/pr_10_ uncertain situation which could be a risk to their 12_candidate_list_20100618.pdf business. ECHA has warmly recommended that companies do not leave it until the last minute.
  • 2. Our article on NCEC newsletter The article “Firms could cut costs by outsourcing regulatory compliance – the evidence” was published on latest issue of UK National Chemical Emergency Centre (NCEC) newsletter Read the full article on http://the- ncec.com/may-2010 looking for chapter 3 “Cut Costs by Outsourcing” New requirements for SDS, amendment to Annex II published An amendment to the REACH Regulation's provisions on Safety Data Sheets was published in the Official Journal New Regulation 453/2010/EC adapts the SDS New SIN List database released provisions in Annex II of REACH to Regulation 1272/2008 on harmonised classification, ChemSec has announced a new user packaging and labelling of substances and interface for version 1.1 of their SIN mixtures, the EU's GHS implementation. (Substitute It Now) list with the aim to help legislators, journalists, consumers, The new MSDS provisions apply from 1 investors and manufacturers retrieve December 2010. information regarding the 356 high- Full text can be downloaded from concern chemicals currently included on the SIN List. http://eur- lex.europa.eu/JOHtml.do?uri=OJ:L:2010:133:SO The database can be consulted at the M:EN:HTML following web address http://www.sinlist.org/ Food flavourings, guidance on the data needed for risk assessment published Additives for use in plastic food The European Food Safety Authority (EFSA) contact materials, updated list has published a guidance about the data An updated version of the provisional list of required for the evaluation of flavourings additives for use in plastic food contact materials and articles has been recently Part A provides a proposal concerning the data published by the European Commission. required for the risk assessment of flavouring substances, i.e. chemically defined substances The list can be downloaded from : with flavouring properties. http://ec.europa.eu/food/food/chemicalsafety/f Part B provides a proposal concerning the data oodcontact/docs/080410_provisional_list_7_2 required for the risk assessment of categories 11009.pdf of flavourings other than flavouring substances for which an evaluation and an approval is required according to Article 9 (b) – (f) of the Regulation 1334/2008/EC on flavourings and certain food ingredients with flavourings Via F.lli Bandiera, 3 properties for use in and on foods I-20020 Arconate (MI) ITALY The document can be downloaded on Mobile : +39-346-740.3491 http://www.efsa.europa.eu/en/scdocs/scdoc/162 info@compliance2business.eu 3.htm?WT.mc_id=EFSAHL01&emt=1 2 - compliance2business newsletter n° – July 2010 2