Workshop on REACH and EU Biocidal Product Legislation in practiceRequirement for polymers and plastic articles within REACH Claude PalateBelgrade May 31st 2012

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Outline of the presentation

• PlasticsEurope: who we are

• Some useful definitions

• Specificities of polymers under REACH• Consequences for plastics producers (M / I)• Consequences for plastics users (DU)

• Authorisation• SVHC

• Consequences for M / I• Consequences for DU

• SVHC in articles

• Restrictions

• Recycling of plastics and REACH

• PEST project

• Conclusions

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PlasticsEurope: a pan-European Organisationof Plastics Producers

BRUSSELS Headquarters

Covering EU-27 plus 4 non-EU states

> 100 European polymers producersrepresenting>90% of all polymers produced

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PlasticsEurope : part of plastics industry

Plastics Industry in Europe:

Employees: 1.600.000

Enterprises: 50.000

Turnover: 300 Bio. €

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Some definitions (1/2)

• Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition

• Monomer: means a substance which is 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

Some definitions (2/2)

• Polymer: means a 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 differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:

• (a) 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;

• (b) less than a simple weight majority of molecules of the same molecular weight.

• Plastic = a polymer of high molecular weight that can be processed into articles

• Compound = ‘ready to use’ mixture of polymer and additives, pigments, fillers etc

• Master-batch = concentrate of specific addtive(s) in a polymer

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Other specificities of monomers and polymers

• Recital 41: Polymers should be exempted from registration and evaluation until those that need to be registered due to the risks posed to human health or the environment can be selected in a practicable and cost-efficient way on the basis of sound technical and valid scientific criteria.

• Art 6(2): For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply (in other words they cannot benefit from the reduction of registration dossier)

• So quite a unique situation compared to the standard substances !

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W. Claes / S.L.-Ophaso - 21/04/23 - 8

Exception

Articles 17 and 18 (‘Light Registration’)

do not apply to monomersArticle 6 § 2

≠New obligation

Polymer manufacturers and importers have to register the monomers

Article 6 § 3

Partial Exemption

Isolated and transported intermediates have to be registered

without further testingArticles 17 & 18

Exemption

Registration and Evaluation do not apply to polymers

Article 2 § 9

General Obligation to Register Substances on their own or in Preparations

Article 6

Registration obligations of polymers

• Art 6 (3) Any manufacturer or importer of a polymer shall 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:

• (a) the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);

• (b) the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.

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Consequences for the polymers

• Polymers manufactured in EU• If the monomers have been registered

• And if the additives used have also been registered

Polymers are then exempt of registrationEasy situation

• Polymers manufactured outside EU• Their importers are responsible of the registration of:

• The monomers

• The additives not necessary for the stability of the polymer

This can be quite a challenge for the importers to obtain all the necessary information related to

• The monomers

• And to additives

used for the production of every imported polymer

• MB and compounds follow the same rules !10

Consequences for the users of polymers

EU users of polymers must ensure that

• Their EU suppliers have well fulfilled all their legal obligations regarding registration and pre-registration

Again, this is a relatively easy situation

• Their non-EU suppliers have appointed an OR to fulfil their legal obligations regarding registration and pre-registration

• If no OR has been appointed, the DU becomes responsible for the registration of the polymers and additives bought outside the EU

There is no registration obligation for articles, unless they contain additives meant to be released (which is not the case with plastics)

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Authorisation – SVHC in plastics

• New substances are regularly added to the Candidate List (2 X /year)• 73 substances today• For the plastics industry, the following 11 substances (mostly used as

additives in plastics) are relevant:• 4 low molecular weight phthalates: DEHP, DBP, DIBP and BBP: all are

plasticisers used in PVC

• 1 phthalate no longer used

• HBCDD: flame-retardant used in PS insulation foam

• 3 Lead chromates, red or yellow pigments

• SCCP: flame retardant

• Acrylamide: monomer

• 8 of the 11 are already in the Annex XIV !• The 4 phthalates, the 3 lead chromates and HBCDD

• With ‘sunset dates’ in 2015

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Consequences for the plastics supply chain of substances becoming SVHC (1/3)

For M / I of plastics containing SVHC:

• Art 31 (1): Obligation to communicate to their DU the presence of SVHC if > 0.1% by updating the SDS

• If < 0.1%, no obligation

• Strong incentive to find suitable alternative(s)

• And / or consider preparing an application of authorisation

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Consequences for the plastics supply chain of substances becoming SVHC (2/3)

For DU of plastics containing SVHC•Production of mixtures (compounds, Master-Batches):

• Same rules as above

•Production of articles:• Art 7 (2): Notify to ECHA

• if > 1 T/a

• and > 0.1%

• and not yet registered for that use

• Art 33 (1): If > 0.1%, provide the recipient of the article with

• The name of the substance

• And sufficient information to allow safe use of the article

• Additives in plastics are generally not meant for intended release

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Consequences for the plastics supply chain of substances becoming SVHC (3/3)

• Consumers / users of articles• Can interrogate the seller about the presence of any SVHC above 0.1%

in the article

• The seller must provide the information

• Free of charge

• Within 45 days

• Complex situation in many cases:• Long supply chains

• Imported articles

• Complex articles

• This highlights the necessity of a good communication along the supply chain

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Consequences for the plastics supply chain of substances included in Annex XIV

• M / I of plastics• Must stop using the substances before sunset date

• But alternatives must be available and suitable

• Or they must apply for an authorisation

• DU of plastics containing Annex XIV substance:

Production of mixtures (compounds, master-batches): • Same rules as above

Production of articles: • Same rules as above

• Important note• Imports into EU of articles containing an Annex XIV substance continue

to be allowed even after sunset date.

• Only a restriction could modify this situation16

Useful ECHA guidance documents

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Authorisation vs Restriction

• Authorisation = all uses are banned except some very limited ones

• Restriction = only certain specific uses are restricted or banned

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Restrictions applied to plastics

• Restrictions are listed in REACH Annex XVII• They apply in general to classified substances, SVHC or substances on

RoI (Register of Intention)• Some examples in plastics (the list is not exhaustive)

• Phthalates in toys• Cadmium pigments in crates• Cadmium in PVC• Lead in PVC• Heavy metals in plastics in general

• New restrictions affecting our industry are currently being examined• Phthalates in indoor use articles• PAHs in consumer articles

• The restriction process is sometimes seen as a ‘fast track’ compared to the Authorisation It can also be seen as complementary

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Recyling of plastics and REACH (1/2)

Another rather complex situation in REACH…

•Recyclers = ‘manufacturers’ of ‘new substances’ (the plastics)• Exempt of registration obligations (of the monomers)

• If they have been pre-registered !

• Additives up to 20% are considered as impurities

• Obligation to have in house SDS of the monomersinvolved

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Recyling of plastics and REACH (2/2)

• Obligation to provide SDS (not eSDS !) if the recycled plastic is classified as hazardous under CLP

• Common situation for plasticised PVC for instance

• Due to the presence of classified phthalates

• Or for old articles containing classified ‘legacy’ additives

• No longer used but present in old articles

• Some specific less stringent restrictions apply to recycled PVC and HDPE to support and ease their recycling

• A SDS-R tool has been set up by EuPR in collaboration with PlasticsEurope to help recyclers to fulfil their SDS obligations

• www.sdsrtool.com

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PEST

PEST = Plastics Exposure Scenario Team

•Team consisting of associations of• Additives producers

• Plastics manufacturers

• MB and compound producers

• Converters

•Aim = producing ES as annex to the SDS for the classified additives present in plastics

•PESTool = web based software, open to members of the PEST associations

• www.pestool.eu

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As conclusion

• Implementing REACH in the plastics industry requires

• Some basic knowledge of the legislation

• Somewhat more of the guidance documents

• Issued by ECHA

• But also by the Cefic (www.cefic.be)

• An even greater amount of organisation skills

• A very good communication up and down the chain

• And really a lot of patience

• To deeply analyse every particular situation

• Draw the correct conclusions

• And try to explain them to your hierarchy

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As conclusion

• Implementing REACH in the plastics industry requires

• Some basic knowledge of the legislation

• Somewhat more of the guidance documents

• Issued by ECHA

• But also by the Cefic (www.cefic.be)

• An even greater amount of organisation

• A very good communication up and down the chain

• And really a lot of patience

• To deeply analyse every particular case

• Draw the correct conclusions

• And finally try to explain them to your hierarchy

• Who will have real difficulties to believe you !

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As conclusion

• Implementing REACH in the plastics industry requires

• Some basic knowledge of the legislation

• Somewhat more of the guidance documents

• Issued by ECHA

• But also by the Cefic (www.cefic.be)

• An even greater amount of organisation

• A very good communication up and down the chain

• And really a lot of patience

• To deeply analyse every particular case

• Draw the correct conclusions

• And finally try to explain them to your hierarchy

• Who will have real difficulties to believe you !

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A special thank you to Walter Claes (EuPC) who kindly shared with me his deep REACH

knowledge and allowed me to use some of his slides

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Hvala