Transcript REACH - Monomers

REACH - Monomers
Monomers
• Following monomers have been pre-registered through Chemexcil
Monomer
CAS No
EINECS No.
No of players in SIEF
1000+
1001000
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
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
Dodecyl methacrylate
142-90-5
205-570-6
Styrene
100-42-5
202-851-5
3870
Maleic anhydride
108-31-6
203-571-6
1910
869
2235
405
Monomers
Monomer
CAS NO
EINECS No.
No of players in SIEF
1000+
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-2methylpropane 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
sodium 2-methyl-2-[(1oxoallyl)amino]propanesulp
honate
5165-97-9
225-948-4
100-1000
10-100
1-10
859
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
Polypropylene
Propylene
Fuel gas
substance
monomer
intermediate
(
)n
monomer unit
O
Propylene oxide
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
Phenol ethoxylatepolymer)
(
O
(
O
n≥3
)n
H
sequence)
(
opened epoxidemonomer
(
unit)
Phenol other
(
reactant)
O
Ethylene oxide monomer)
(
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% (✓)
Polymer Confidentiality issue
Monomer
%
Polymer import (MT)
2.2
3
20 55
100
1.5
10 27.5 50
Butyl acrylate
50
1.1
Methyl
methacrylate
40
0.88 1.2
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
8
22
Exceed threshold limit 1 MT
40
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 preregistered 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?