reach - monomers. monomers following monomers have been pre-registered through chemexcil monomercas...
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REACH - Monomers
Monomers• Following monomers have been pre-registered through Chemexcil
Monomer CAS No EINECS No. No of players in SIEF
1000+ 100-1000
10-100 1-10
Ethylene oxide 75-21-8 200-849-9 395 - 2472 -
Methyl oxirane 75-56-9 200-879-2 - - 1642 265
Acrylamide 79-06-1 201-173-7 869
Buta-1,3-diene 106-94-5 203-450-8 14
Propene 115-07-1 204-062-1 3109
Ethylene 74-85-1 200-815-3 4042
Acrylonitrile 107-13-1 203-466-5 2235
Dodecyl methacrylate 142-90-5 205-570-6 405
Styrene 100-42-5 202-851-5 3870
Maleic anhydride 108-31-6 203-571-6 1910
Monomers
Monomer CAS NO EINECS No. No of players in SIEF
1000+ 100-1000 10-100 1-10
Terphthalic acid 100-21-0 202-830-0 2415
Ethane-1,2-diol 107-21-1 203-473-3 4029
Isophthalic acid 121-91-5 204-506-4 1907
2-Acrylamido-2-methylpropane sulphonic acid
15214-89-8 239-268-0 372
Vinyl acetate 108-05-4 203-545-4 2793
Isoprene 78-79-5 201-143-3 859
sodium 2-methyl-2-[(1-oxoallyl)amino]propanesulphonate
5165-97-9 225-948-4 306
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
Monomers
( )n
O
Propylene Polypropylene
Propylene oxide
Fuel gas
monomer unit
monomer
intermediate
substance
Monomer unit = reacted form of monomer
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)
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
ECHA Guidance document Page 12 last para
REACH - Polymers
• Polymers:– Only monomers must be registered if polymer contains
>2% of reacted monomer and annual volume exceeds 1 t/a
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
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
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
Polymers
Example 1 Example 2 Example 3
n = 1 0% 40% 5%
n = 2 10% 20% 10%
n = 3 85% 15% 20%
n = 4 5% 12% 30%
n = 5 0% 8% 20%
n = 6 0% 5% 10%
n = 7 0% 0% 5%
Sum 100% (X) 100% (X) 100% (✓)
O( O
H
Phenol ethoxylate (polymer)
)n
Phenol ( other reactant) opened epoxide (monomer unit)
O
Ethylene oxide ( monomer)
n≥3
(sequence)
Polymer Confidentiality issue
Monomer % Polymer import (MT)
2.2 3 20 55 100
Butyl acrylate 50 1.1 1.5 10 27.5
50
Methyl methacrylate
40 0.88 1.2 8 22 40
Ethyl acrylate 6 0.13 0.18
1.2 3.3 6
PM1 2.5 0.06 0.08
0.5 1.4 2.5
PM2 1.5 0.03 0.05
0.3 0.8 1.5
Exceed > 2% wt Exceed threshold limit 1 MT
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.
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.
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?