NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS

Legal name of applicant(s): DEZA a.s.

Submitted by: DEZA a.s.

Substance: BIS(2-ETHYLHEXYL) (DEHP)

Use title: Formulation of DEHP in compounds, dry blends and plastisol formulations

Industrial use in processing by calendering, spread coating, extrusion, to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)]

Use number: Uses 1 and 2 NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS

1. Introduction

DEHP’s main function is that of a plasticiser in soft PVC. This Application for Authorisation (AfA) covers exclusively the formulation and use of DEHP as a plasticiser to produce articles from soft PVC (for specification of articles not covered by this AfA, see below).

As a first step, DEHP is formulated into PVC compounds, plastisol formulations and dry-blends, in industrial settings. The formulation of DEHP in non-polymer preparations is not covered in this AfA.

Use of the formulated DEHP PVC compounds and dry-blends can take place at the same industrial sites involved in the formulation or at other industrial sites after transport. Compounds are then converted into final articles via different processes i.e. calendering, spread coating, extrusion, injection moulding. This application seeks authorisation for two uses within a single supply chain: formulation into PVC matrices and use in polymer processing of these formulations to produce PVC articles.

The table below lists the uses, for which authorisation is requested.

Identified use #1: Formulation of DEHP in compounds, dry-blends and plastisol formulations

#2: Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)]

As mentioned above, this application covers all the relevant industrial steps related to the use of DEHP in the production of various PVC articles, including the most common methods for compounding (preparation of dry- blends and plastisol) and processing (calendering, spread coating, extrusion, injection moulding).

No authorisation is sought for professional or consumer end uses of mixtures containing DEHP or the substance itself and for use of DEHP in other matrices than PVC. For example, use in modelling clay and similar uses are not supported by this application. The only industrial end use included in this AfA is use of DEHP for production of PVC articles. This application does not include the uses of DEHP to produce the following PVC articles: - erasers - adult toys (sex toys and other articles for adults with intensive contact with mucous membranes) - small (<10 cm) PVC items available in the home environment (without attachment to larger objects), which can be swallowed by small children - textiles/clothing with direct contact to large skin surfaces (worn on bare skin).

In addition, the application specifically excludes the use of DEHP in toys, cosmetics and food contact material as these are regulated by other EU legislation.

2 NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS Exposure to workers

Industrial workers

Exposure of industrial workers to DEHP occurs during the formulation of DEHP as well as during the production of PVC articles (polymer processing by calendering, spread coating, extrusion, injection moulding)

Professional and industrial workers Professional and industrial workers may be exposed to DEHP from PVC articles during their service life. Exposure from the service life stage is considered to be identical for professional and industrial workers. They are covered by the the contributing scenarios for exposure scenario ES3 (ES3-SL-P1 and ES3- SL-P2 in Table 1).

Consumer exposure

This AfA covers only industrial uses of a substance up to the point of incorporation into an article. However, the REACH Regulation stipulates that an AfA must be accompanied by a CSR and a CSR requires the inclusion of assessment of service life. In the case of DEHP, this means that the CSR includes an assessment of consumer exposure to articles which contain PVC plasticised with DEHP.

The exposure scenarios (with contributing scenarios) established for these applied for uses are listed in the following table (overleaf), and are presented in greater detail in sections 2 and 3 of this document:

3 NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS

TABLE 1

Resulting y Identified uses life cycle stage gor cate

)

e C )

s )

O )

C R e C s elea

P s P r

ticle

( ( u

A r

e e

( a s y

y s

d

u SU) r

y u r

(

d gor d En

gor e fo

tal

(fo

n

e n s

n n e e e

E e ate ate U ur g

er C f C li f on al e

ta

gor cate i ial o

nm s lati o

act s

r

m pp lied t o r ss um a r s ice a title te o i

no . n ce s s nuf

e e ticle rv RC ) a s s r on s S S ormu rof e ct rodu ro U U E E Ma F Indu P C Se W Sect P P A Env (E #1 Formulation of

DEHP in 1, 2, 3, 4, Formulation of DEHP in compounds, dry- 10, compounds, dry- ES2 x x 32 5, 8b, 14, 2, 3 blends and plastisol formulations 12 blends and plastisol 15 formulations #2 Industrial use in polymer processing by Industrial use in calendering, spread coating, extrusion, polymer processing injection moulding to produce PVC by calendering, 2, 3, 4, 6, articles [except erasers, sex toys, small spread coating, 8b, 10, ES3 household items (<10cm ) that can be x x 12 32 13 5 extrusion, injection 13, 14, swallowed by children, clothing intended moulding to to be worn against the bare skin; also toys, 21 produce PVC cosmetics and food contact material articles [except (restricted under other EU regulation)] erasers, sex toys, Contributing Scenario: small household ES3- Service life professionals*: Professional 10a, items (<10cm ) that x P x 21 13 can be swallowed SL-P1 handling of PVC products: Installation of 11a by children, building materials and similar activities clothing intended to Contributing Scenario: be worn against the ES3- Service life professionals*: Professional bare skin; also toys, x IP x 13 11a SL-P2 and industrial workers wearing PVC work cosmetics and food clothes and (waterproof

4 NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS

contact material overall/rainwear, waterproof , clogs) (restricted under Contributing Scenario: ES3- 10a, other EU Service life consumers: exposure from x C x 13 regulation)] SL-C1 11a consumer articles * These service life scenarios were developed for professional workers, but equally apply to industrial workers because exposure is not expected to differ between professional and industrial workers for these scenarios

5 NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS

2. Use #1: Formulation of DEHP in compounds, dry-blends and plastisol formulations

ES2: Formulation of DEHP in compounds, dry-blends and plastisol formulations Use descriptors related to the life cycle stage and all the uses under it: SU 10,12 – PROC 1, 2, 3, 4, 5, 8b, 14, 15 – PC 32 – ERC 2, 3 Contributing exposure scenario ES2-W1 controlling worker exposure Formulation of DEHP in compounds, dry-blends and plastisol formulations (PROC 1, 2, 3, 4, 5, 8b, 14, 15) Covers the material receipt, preparation, reaction, pelletisation, bulk transfer and storage, as well as equipment cleaning, and associated maintenance activities as well as use in laboratories Product characteristic Liquid / physically dispersed in a solid matrix at the end of the dry-blend, compounds formulation Low volatility liquid [OC3] / Solid, low dustiness [OC1] Limit the substance content in the mixture to 50% [OC22] Other given operational conditions affecting workers exposure For dry blending and compounding: Some operations are carried out at elevated temperature [OC7] For plastisol formulation: Assumes activities are at ambient temperature (unless stated differently) [G17]

ES2-W1: Formulation of DEHP in compounds, dry-blends and plastisol formulation Process PROC PROC 1 – Use in closed process, Closed continuous process, Indoors no likelihood of exposure PROC 2 – Use in closed process, General exposures (closed systems); With continuous process with occasional sample collection; Indoors controlled exposure General exposures (closed systems); With PROC 2 – Use in closed process, sample collection; Elevated process temperature continuous process with occasional Indoors, with LEV present controlled exposure

Batch closed process exposures; Indoors, with PROC 3 – Use in closed batch The CSR LEV present process (synthesis or formulation) demonstrates that Batch closed process exposures; Elevated PROC 3 – Use in closed batch there is no risk from process temperature; Indoors with LEV present process (synthesis or formulation) exposure to DEHP Batch closed process exposures; Elevated PROC 3 – Use in closed batch for industrial process temperature; Indoors process (synthesis or formulation) workers.

PROC 4 – Use in batch and other Batch process exposures; Elevated process The risks are process (synthesis) where temperature; Indoors opportunity for exposure arises adequately controlled. PROC 5 – Mixing or blending in

batch processes for formulation of Continuous or batch mixing processes for preparations and articles plastisol formulation of DEHP; Indoors (multistage and/or significant contact) PROC 8b – Transfer of substance or preparation Drum/batch transfers of DEHP and of liquid (charging/discharging) from/to formulation; Dedicated facility; Outdoors vessels/large containers at dedicated facilities Drum/batch transfers of DEHP and of liquid PROC 8b – Transfer of substance

6 NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS

formulation; Dedicated facility; Indoors with or preparation LEV (charging/discharging) from/to vessels/large containers at dedicated facilities PROC 8b – Transfer of substance or preparation Drum/batch transfers of solid formulation; (charging/discharging) from/to Dedicated facility; Indoors with LEV vessels/large containers at dedicated facilities PROC 14 – Production of Production of preparations or articles by preparations or articles by tabletting, compression, extrusion, pelletisation; tabletting, compression, extrusion, Solid formulation; Indoors with LEV pelletisation PROC 14 – Production of Production of preparations or articles by preparations or articles by tabletting, compression, extrusion, pelletisation; tabletting, compression, extrusion, Liquid formulation; Indoors with LEV pelletisation Quality control in laboratory; Indoors with fume PROC 15 – Use as laboratory cupboard reagent

7 NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS

3. Use #2: Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)]

ES3: Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] Use descriptors related to the life cycle stage and all the uses under it: SU 3, 12 – PC 32 – PROC 2, 3, 4, 6, 8b, 10, 13, 14, 21 – AC 13 – ERC 5 Contributing exposure scenario ES3-W1 controlling worker exposure Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)] (PROC 2, 3, 4, 6, 8b, 10, 13, 14, 21) Covers the transferring and processing of formulations containing DEHP as well as equipment cleaning, and associated maintenance activities. Includes low energy manipulation of the resulting Product characteristic Liquid for plastisol/physically dispersed in the solid dry-blend formulation Low volatility liquid [OC3]/ Solid, low dustiness [OC1]. Solid polymer articles are processed by extrusion (PROC 14) or low energy manipulation processes (PROC 21). Limit the substance content in the mixture to 50% [OC22] Other given operational conditions affecting workers exposure For calendering, compounding, spread coating, extrusion, injection moulding: some operations are carried out at elevated temperature in closed systems: up to 180°C. Some activities involving operator’s action take place at temperatures higher than ambient: the maximum temperature in those cases is estimated to be 40°C

ES3-W1: Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation) Process PROC

PROC 2 – Use in closed, continuous General exposures (closed systems); Indoors process with occasional controlled with LEV The CSR exposure demonstrates that Batch closed process exposures; Indoors with PROC 3 – Use in closed batch there is no risk LEV process (synthesis or formulation) from exposure to PROC 4 – Use in batch and other DEHP for Batch process exposures; Indoors with LEV process (synthesis) where industrial workers. opportunity for exposure arises Calendering operations with liquid The risks are PROC 6 – Calendering operations formulations, Indoors with LEV adequately PROC 8b – Transfer of substance or controlled Drum/batch transfers of DEHP and of liquid preparation (charging/discharging) formulation; dedicated facility; Indoors with from/to vessels/large containers at LEV dedicated facilities

8 NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS

Roller or brushing applications, with liquid PROC 10 – Roller application or formulations, Indoors with LEV brushing Dipping, pouring, spread coating applications PROC 13 – Treatment of articles by with liquid formulations, Indoors with LEV dipping and pouring PROC 14 – Production of Extrusion, tabletting, compression, preparations or articles by tabletting, pelletisation operations , Indoors with LEV compression, extrusion, pelletisation Extrusion, tabletting, compression, PROC 14 – Production of pelletisation operations with liquid preparations or articles by tabletting, formulation, Indoors with LEV compression, extrusion, pelletisation PROC 21 – Low energy Low energy manipulation of articles such as manipulation of substances bound in cutting, welding, gluing, Indoor with LEV materials and/or articles

Contributing scenario ES3-SL-P1/P2 controlling worker exposure Article service life: Professional handling of PVC products: Installation of building materials and similar activities (PROC 21) (ES3-SL-P1) Handling of PVC products containing DEHP by craftsmen, such as the installation of roofing, flooring, HVAC products or coated steel wire mesh fencing. Typical tasks include manual cutting, assembling and disassembling soft PVC articles, which are considered to lead to dermal exposure only. Additional inhalation exposure may exist in specific situations, e.g. for storekeepers in retail outlets, where large amounts of DEHP-plasticised PVC articles are stored and handled manually at the same time or for workers occupied in rooms with large PVC surfaces, such as large-scale PVC flooring. These exposures are primarily relevant for professional workers, but similar situations may exist for industrial workers and are therefore also covered by this scenario. DEHP is only contained in plasticised PVC articles (soft PVC), which are not handled by dust-generating processes, also described by PROC 21.

Article service life: Professional and industrial workers wearing PVC work clothes and footwear (waterproof overall/rainwear, waterproof boots, clogs) (no PROC) (ES3-SL-P2). Note – this relates to clothing that is not worn against the bare skin. It covers the wearing of PVC clothing and footwear by professional and industrial workers. A typical example is a fisherman wearing waterproof PVC clothes together with PVC footwear

Article characteristic Installation of building materials and similar activities (ES3-SL-P1) Articles handled are made of PVC () or composite materials, such as coated steel wire mesh fencing and wood-PVC composite materials. This contributing scenario covers the handling of PVC articles primarily by craftsmen, such as: roofing and flooring products, HVAC products and coated steel wire mesh fencing. It also covers PVC articles handled by workers in other professions, e.g. office clerks, landscape gardeners, shop assistants, such as: office supplies (such as files, cases and ring binders), outdoor products (such as garden hoses and tubes, wood-PVC composite profiles (fences, patio profiles)) and many other items (e.g. packaging material, tape and self-adhesive foils, haberdashery, luggage, briefcases, bags, rainwear, footwear as well as curtains and blinds), as exposure (in terms of skin surface exposed and/or exposure duration/frequency) is obviously lower compared to daily dermal contact for several hours to building materials by craftsmen.

Workers wearing PVC work clothes and footwear (ES3-SL-P2) Articles worn are made of soft PVC (plastic). This contributing scenario covers waterproof clothes ( and or overall) and footwear (boots), as worn e.g. by professional fishermen, but also e.g. in the food industry. It also covers non-waterproof footwear, such as clogs and safety worn in the professional environment, e.g. by hospital staff, pool attendants etc.

9 NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS Other given operational conditions affecting workers exposure

10 NON-CONFIDENTIAL SUMMARY OF EXPOSURE SCENARIOS

Assumes use at not more than 20°C above ambient temperature, unless stated differently [G15]

PROC ES3-SL-P1: Service Life Professional handling PROC 21 – Low energy The CSR demonstrates of PVC products: Installation of building manipulation of substances that there is no risk from materials and similar activities bound in materials and/or exposure to DEHP for articles professional workers. ES3-SL-P2: Service Life Professional and Not applicable industrial workers wearing PVC clothes and The risks are adequately footwear controlled

ES3-SL-C1: Service life consumers: Exposure from consumer articles ES3-SL-C1 covers dermal exposure from consumer contact with PVC articles. For some PVC articles, oral exposure (primarily mouthing) is addressed as well. This scenario also covers oral and inhalation exposure in the indoor environment that cannot be attributed to specific articles. The following consumer articles are not considered and not covered by this application: - erasers - adult toys (sex toys and other articles for adults with intensive contact with mucous membranes) - small (<10 cm) PVC items available in the home environment (without attachment to larger objects), which can be swallowed by small children - textiles/clothing with direct contact to large skin surfaces (worn on bare skin) Article characteristic Articles are made of soft PVC (plastic) Human factors not influenced by risk management Three age groups (adults, children 6-12 months old, children 2-3 years old) are considered to reflect a range of exposures at different ages

ES3-SL-C1: Service life consumers: Exposure from consumer articles Article groups Type of article covered D1: Dermal exposure from PVC flooring PVC flooring, cork with PVC -coating, and similar articles bath mats D2: Dermal and oral exposure from Table linen, haberdashery, luggage,

smaller PVC articles (non-foil/film-like) briefcases, bags D3: Dermal and oral exposure from Packaging, tape and self-adhesive foils smaller PVC articles (foil/film-like) The CSR D4: Dermal and oral exposure from PVC demonstrates that rainwear there is no risk D5: Dermal exposure from PVC from exposure to , clogs, footwear with direct skin contact DEHP for Balance balls for exercise, office supplies consumers (adults (files, slip cases, ring binders), garden hoses and children). D6: Dermal exposure from PVC articles and tubes, wood-PVC composite profiles

with infrequent contact (fences, patio profiles), tarpaulins, tents, The risks are injected seals, footwear outer soles, adequately insulating films controlled. Inflatable pools, inflatable boats, swimming D7: Dermal exposure from PVC articles , swimming wings and injected seals used in/on water (mouthpiece of snorkel) D8: Dermal exposure from PVC articles Waterbeds, upholstery, car seats, sleeping (prolonged contact) mats, air mattresses

11