Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01 REACH and paper chemicals Liisa...
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Transcript of Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01 REACH and paper chemicals Liisa...
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
REACH and paper chemicals
Liisa Rapeli-Likitalo, EPCG (Ciba Specialty Chemicals Oy)
European Paper Week 2005December 1, 2005
Sheraton Rogier Hotel, Brussels
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
REACH and paper chemicalsAssessment based on 1st reading of European Parliament
•Paper chemicals from regulatory point of view
•REACH and R&D
•Some examples of products
•Future
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
Paper chemicals
• Most are HPV–substances (> 1000 t per year)– Even special additives > 1 t per year
• A number of nature based chemicals– Modified– Annex II and III – content and interpretations
• Complicated reaction mixtures and poorly soluble substances– Testing
• Many substances have long history of use, old test data – not under GLP
• NLPs, No Longer Polymers, e.g. emulsifiers
• A number of functional polymers– Many starting substances will need authorisation
• Time from idea to market will be longer
• Paper machines are sensible for changes in products
• A number of customized products
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
R&D - Pulp and paper chemicals
• Many additives and process chemicals, e.g.
• Solvents• Initiators, catalysts• Chain transfer agents• Emulsifiers, surface active agents• Antioxidants• Plasticizers• Stabilizers• Release agents• pH Regulators• Stripping chemicals• Defoamers• Biocides
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
REACH – Something to gain
+ R&D and PPORD+ Longer than current PORD 5+10 years + Only one application dossier, not separately in every MS:
Agency Same fee and equal opportunity
+ Volume versus application
+ Categories and read across+ Possibility to play around the molecules and find/use
”new” molecules without full testing dossier+ Annex II?+ Practice?
+ More data publicly available
+ Learning from each other?
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
REACH – Concerns for paper chemicals• List of available chemicals will be shorter than
today– EINECS: 100 116 entries– ELINCS: ~5000– + NLP:s, No Longer Polymers– Future: ~ 30 000 +/- xxxx?
• Practice– Interpretations– Annex II and III– Exposure based waiving…
• OSOR– Workability
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
REACH – Concerns for paper chemicals
• Chemical Safety Assessment and Chemical Safety Report (>1 t/y) – Risk Management Measures included– Covers also marine environment– Exposure scenarios
• Paper making and recycling– Exposure and use categories– Communication in safety data sheets
• Authorisation may require a lot of resources– Substitution and research in order to find alternatives => ”Defensive R&D”– Socio Economic Analysis / Methodology – Time limited (5 years)– Can be opened by third party intervention– Many monomers and other starting substances for
polymers used by paper industry will require authorisation • e.g. acrylamide, acrylonitrile, butadiene,
epichlorohydrin…
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
How to find alternative substances?
Active structural groups = reactive groups
Other approval processes may take years to complete, e.g. food contact compliance
Substances with long history of use are known
– Test results, exposure data exist– Technical performance known– Availability
• Production processes and facilities • Raw materials
– Reasonable price
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
How to find alternative substances?
•Possible change in the composition of paper chemicals =>
– Literature & desktop research– Laboratory trials– Pilot trials – Production trials– Application trials: by the producer of the chemical
+ customer pilots– Mill trials
Easily a couple of years and yyy yyy € or y yyy yyy €
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
REACH requires resources
• All functions of a company will be effected– Purchasing– R&D, e.g. laboratories
• Substance identity, impurities, side reaction products etc.• Physico chemical properties• Registration and authorisation dossier and CSR
> Different uses • Dosage, content/residues in intermediates and final
products, exposure measurements> Emission/Effluent measurements
• Air, water, waste water treatment plants (including sludge), soil, sediment
> Recycling and disposal…• R&D in future more defensive than real R&D
– Production– Sales– Administration
• ”REACH Competence Centers” (including ”office chemists”)• IT…
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
REACH AND PAPER CHEMICALS - Examples
• Styrene acrylate based polymeric size
– Polymers exempted from REACH for the time being but new Safety Data Sheets, SDSs for the products have to be prepared
– Monomers and other starting substances have to be registered, HPV chemicals => Chemicals Safety Report, CSR and new SDSs
• Own production and importation but EU-RA, ICCA Initiative and EPA HPV program data exist for main monomers
• Specific monomers, initiators, emulsifiers, pH regulators, defoamers etc.
> Make sure that they will be available, PBT or vPvB… or prepare for defensive R&D
> Possible data gaps…
• Food contact approvals exist => this use is exempted from CSR
• Styrene possible endocrine disruptor - authorisation?
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
PAPER CHEMICAL EXAMPLES
• Calcium distearate
– Annex II – pure!
• Annex II: ”Substances commonly found in foodstuffs, such as citric acid, sugar, oils, fatty acids, etc.”
– Adipic acid (E 355), citric acid (E 330)
– Casein?
– Fatty acids and their derivatives as deinking chemicals?
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
REACH & paper chemicals
• Details and interpretations still open
• Basic volume chemicals - bulk– No remarkable changes foreseen yet– Some additives may be ”lost” which may cause additional
workload and cost effects
• Specialty chemicals– Some pressure on further testing
• Long term effects• Testing problems
• Substitution is very difficult
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
REACH - Cooperation of mills and chemicals’ suppliers
Management of chemical know how• ERP systems• Data per substance versus products• Communication
– Questionnaires and safety data sheets
Registration, evaluation and authorisation
• Substance information: Suppliers!
• Chemical Safety Reports
– Help from customers will be needed– Exposure scenarios– Compare to current EU Risk Assessment
Liisa Rapeli-Likitalo and Peter Ungeheuer 2005-12-01
REACH – Future
• Resources?• Prices • New type of business with
– REACH compliant chemicals – IPR
• Data ownership• Registration and authorisation dossiers and numbers
But paper will be made and paper chemicals will be manufactured and developed even when REACH is in force…