Liisa Rapeli-Likitalo and Peter Ungeheuer REACH and paper chemicals Liisa Rapeli-Likitalo, EPCG (Ciba Specialty Chemicals Oy) European Paper Week 2005 December 1, 2005 Sheraton Rogier Hotel, Brussels

Liisa Rapeli-Likitalo and Peter Ungeheuer REACH and paper chemicals Assessment based on 1 st 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 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 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 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 REACH – Concerns for paper chemicals List of available chemicals will be shorter than today –EINECS: entries –ELINCS: ~5000 –+ NLP:s, No Longer Polymers –Future: ~ /- xxxx? Practice –Interpretations –Annex II and III –Exposure based waiving… OSOR –Workability

Liisa Rapeli-Likitalo and Peter Ungeheuer 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 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 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 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 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 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 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 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 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…