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REACH - Monomers

REACH - Monomers

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REACH - Monomers

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  1. REACH - Monomers

  2. Monomers • Following monomers have been pre-registered through Chemexcil

  3. Monomers

  4. Monomers – REACH definition • Article 2(6): Substances which are capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer forming reaction used for the particular process. • Catalysts, initiators, terminators of the polymer are not monomers • By definition Monomer is an intermediate, nonetheless under REACH provisions for registration of intermediates do not apply to monomers • For application outside polymers, the same substances are not regarded as monomers

  5. Monomers Monomer unit = reacted form of monomer

  6. Monomer - Substance or intermediate? • Article 2.15 : Intermediate means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (or synthesis) • Non-isolated intermediates ( not intentionally removed during synthesis) • On-site isolated ( manufacture of intermediate and that of the other substance manufactured from this intermediate takes place on the same site • Transported isolated intermediate ( intermediate transported between or supplied to other sites)

  7. REACH – reduced obligations • Article 2 (8) • On-site isolated intermediates and transported isolated intermediates shall be exempted from • (a) Chapter 1 of Title II (Registration) with the exception of Articles 8 & 9 and • (b) Title VII (Restrictions on mfg and use of certain dangerous substances & preparations) • Article 2 (9) • The provisions of Titles II (Registration) and VI (Evaluation) shall not apply to polymers

  8. ECHA Guidance document Page 12 last para

  9. REACH - Polymers • Polymers: • Only monomers must be registered if polymer contains>2% of reacted monomer and annual volume exceeds 1 t/a

  10. Polymers under REACh • Article 2(9): The provisions of Titles II (Registration) and VI (Evaluation) shall not apply to polymers [M / I of a polymer is generally not required to provide to the Agency any information related to the intrinsic properties of the polymer itself, with the exception of its C & L] • Article 6(3): Any M / I of a polymer shall 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: • The polymer consists of 2% w/w or more of such monomer or other substance in the form of monomeric units and chemically bound substances. • and • The total quantity of such monomer substance or other substance [i.e. the quantity of these substances ending up in the final polymer as unbound or chemically bound to the polymer] makes up ≥1 tonne per year

  11. Polymer – definition under REACH • REACH [Article 3(5)] : – criteria for polymer • Substance consisting of molecules characterised by the sequence of one or more types of monomer units, Such molecules must be distributed over a range of molecular weights, wherein the molecular weight are primarily attributed to difference in the number of monomer units • A simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant • Less than a simple weight majority of molecules of the same molecular weight • In other words • >50% of the weight for that substance consists of polymer molecules and • The amount of polymer molecules presenting the same molecular weight must be <50 weight % of the substance

  12. Polymer – definition under REACH • This definition has a great impact. • Polymer emulsions, solutions or suspensions and polymer based products such as paints, inks, coatings shall be regarded as “formulations” or “preparations’ and not substances or polymers. • Unbound additives, solvents or emulsion stabilizers ( not polymer stabilizers) will have to be registered if manufactured or imported into the EU in quantities > 1 ton/year. • Additives which are required to stabilize the polymer itself, such as antioxidant will be considered as a part of the polymer itself and need not be registered

  13. Polymers Phenol ethoxylate (polymer) n≥3 O H (sequence) ( ) n O opened epoxide (monomer unit) Phenol ( other reactant) O Ethylene oxide ( monomer)

  14. Polymer Confidentiality issue Exceed > 2% wt Exceed threshold limit 1 MT

  15. No longer polymers (NLP) • Under Directive 67/548/EEC for notification of new substances • Polymers were subject to special rules. • 7th amendment 92/32/EEC defined the term polymer. • Thus some substances which were considered to be polymers under EINECS now were “No longer Polymers” • Polymers were not reportable in EINECS. • All substances not listed in EINECS are notifiable • Thus NLP would become notifiable • Under 7th amendment substances from the NLP list which were on the EU market between 18.09.1981 to 31.10.1993 were not to be restrospectively affected if they were included in this NLP list.

  16. No longer polymers (NLP) • NLP list consists mainly of following groups • Alkoxylated substance • Oligomeric reaction products • Dimers and trimers • Oligomers from one monomer only • Polymer-like substances containing 50% or more by by weight of species with same molecular weight.

  17. Questions • Are you manufacturing and exporting monomers to EU? • Are you exporting products manufactured using the monomers pre-registered as you? • Are you importing monomers from EU and using them to make products which you export to EU ? • If so has your EU supplier pre-registered the monomer ? • Are you importing monomers from non-EU countries? • Do the products exported by you meet the definition of polyemers under REACH?