Submission of information on
TEMPLATE
for third party submission of information on alternatives for
Applications for Authorisation
NON-CONFIDENTIAL
Legal name of submitter(s):
European Environmental Bureau (EEB)
[0008-02] [several alternatives] [8/1/14]
TABLE OF CONTENTS
1. ALTERNATIVE ID AND PROPERTIES
Alternatives to DEHP used in the production of recycled soft PVC articles include alternative materials and
alternative technologies that avoid the use of DEHP. Many downstream users are phasing out DEHP and
PVC and therefore different alternatives are available in the market.
The following sources provide information on alternatives in different sectors:
Construction materials and products

http://www.healthybuilding.net/pvc/alternatives.html

TURI: "Five Chemicals Alternatives Assessment Study" report, Chapter 7, "DEHP" (AVAILABLE AT:
http://www.turi.org/TURI_Publications/TURI_Methods_Policy_Reports/Five_Chemicals_Alternatives
_Assessment_Study._2006)
Floorings

http://www.cbcflooring.com/ceres/index.html

TURI: "Five Chemicals Alternatives Assessment Study" report, Chapter 7, "DEHP" (available at:
http://www.turi.org/TURI_Publications/TURI_Methods_Policy_Reports/Five_Chemicals_Alternatives
_Assessment_Study._2006)
Healthy & Sustainable Flooring, choosing resilient flooring for the European healthcare sector
(available at: http://www.noharm.org/lib/downloads/chemicals/2012_Flooring_report_dp.pdf)

SUBSPORT:

Substitution of PVC floorings (available at: http://www.subsport.eu/case-stories/123-en?lang=)

An alternative to phthalates: Novel plastic softener produced from castor oil and acetic acid
(available at: http://www.subsport.eu/case-stories/205-en?lang=)
Electronics

http://www.greenpeace.org/international/en/Guide-to-Greener-Electronics/18th-Edition/

http://www.dell.com/learn/us/en/uscorp1/corp-comm/earth-greener-products-materials

SUBSPORT: Proactively eliminating the phthalates DEHP, BBP, DBP and DIBP from electronic
products (available at: http://www.subsport.eu/case-stories/304-en?lang=)
Wires and cables

AMEC Analysis of alternatives for a group of phthalates. Final Report. RIVM - Dutch National
Institute for Public Health and the Environment. 2013 (attached as ‘Analysis of alternatives for a
group of phthalates - AMEC final report’)

Green Chemistry and Commerce Council Consortium report (See:
http://www.greenchemistryandcommerce.org/documents/PilotProjectFullReportOct2-final_000.pdf.
See overview of the project at:
http://www.greenchemistryandcommerce.org/documents/BusinessandAcademicPartnershipsforSafer
Chemicals-RT2013.pdf)

HDP'S analysis of halogen free cables project.
http://www.pcbdesign007.com/pages/zone.cgi?artcatid=0&a=80209&artpg=1&artid=80209&pg=1
SUBSPORT:

Polyvinyl chloride (PVC) Power Cord Alternatives (available at: http://www.subsport.eu/casestories/114-en?lang=)

Cables without lead, PVC and phthalates (available at: http://www.subsport.eu/case-stories/039en?lang=)
Textiles, fabrics and waterproof fabrics

http://www.alibaba.com/showroom/pvc-free-waterproof-fabric.html

Healthy Business Strategies for Transforming the Toxic Chemical Economy. Clean Production
Action. (Attached as ‘CPA_Bus_Strategies_26jun06_FINAL’)
SUBSPORT:

Substitution of phthalates in textile print applications (available at: http://www.subsport.eu/casestories/377-en?lang=)

Substitution of phthalates from childrenswear prints (available at: http://www.subsport.eu/casestories/373-en?lang=)

An alternative to PVC and phthalates in high density plastisol prints (available at:
http://www.subsport.eu/case-stories/371-en?lang=)
Furniture

Healthy Business Strategies for Transforming the Toxic Chemical Economy. Clean Production
Action. (Attached as ‘CPA_Bus_Strategies_26jun06_FINAL’)

Kruopiene, J. et al. Use and Substitution of DEHP in Lithuanian Furniture Industry. Environmental
Research Engineering and Management, 2004, 4 (30), 61-65.
Automobiles

http://www.healthystuff.org/documents/2012_Cars.pdf
OTHER DOCUMENTS CONTAINING SPECIFIC ALTERNATIVES TO DEHP AND ALTERNATIVE
PLASTIC MATERIALS:

Analysis of alternatives for a group of phthalates, Final Report. RIVM - Dutch National Institute for
Public Health and the Environment & AMEC Environment & Infrastructure UK Limited. December
2013.

“Product design screening method helps reduce toxic materials in consumer goods”. European
Commission (available at:
http://ec.europa.eu/environment/integration/research/newsalert/pdf/323na6.pdf)

“Environmentally Friendly Plastics”. In a new study, researchers from the University of Minnesota
have developed a portfolio of degradable plastics derived from renewable resources that could serve
as a viable alternative to plastics made from petroleum and natural gas. Marc Hillmyer, Distinguished
McKnight University Professor of chemistry and director of the Centre for Sustainable Polymers in
the College of Science and Engineering. Environmental Protection News, 26 April 2011
http://www.eponline.com
2. TECHNICAL FEASIBILITY
Technical feasibility is demonstrated by the fact that these alternative materials and
technologies are in use.
3. ECONOMIC FEASIBILITY
Economic feasibility is demonstrated by the fact that these alternative materials and
technologies are in use.
4. HAZARDS AND RISKS OF THE ALTERNATIVE
[Insert text here]
5. AVAILABILITY
DEHP and PVC free alternatives are easily found in the market place.
6. CONCLUSION ON SUITABILITY AND AVAILABILITY OF THE ALTERNATIVE
[Insert text here]
7. OTHER COMMENTS
Insufficient information is provided in the public consultation
The information provided for the public for the public consultation doesn’t include information on key
elements of the uses of DEHP’, such as: use service (end-use, service life and life cycle), performance level
(volumetric use or quantities, full exposure scenarios, real exposure data, full description of the process,
production, applicable use, etc.) and functional use (use function). The information on environment and
human exposures is also very limited or non existent, as only a very general description of the exposure
scenarios is provided. Only very general statements about the economic and social costs of the refusal of an
authorization are published. Information such as occupational health prevention costs, environmental
protection costs (waste water, emissions, air, waste management and treatment, etc.), costs of having
DEHP/PVC in plastic waste streams (landfilling, recycling, incineration, etc.) or health costs of diseases
related to DEHP is also missing. Furthermore, there is a general lack of information on social benefits; the
only social benefit referred to in the application is the improvement in male reproductive health, although no
quantification of this improvement is provided.
This information would provide a clear understanding on why and how the SVHC is used and enable third
parties to better understand whether their alternatives are economically and technically feasible for the
applicant.
As a consequence, relevant information is not accessible to third parties during the public consultation,
hindering stakeholders’ meaningful and effective participation in the authorization process.
All information provided during the authorisation process should be made publicly available as it refers to
substances of very high concern with wide dispersive use, produced in high volumes.
Adequate control of workers’ and consumers’ exposure to DEHP is not demonstrated
It is very difficult if not impossible to assess the exposure to DEHP due to the lack of information provided in
the public consultation. However some figures should be considered:
Post-consumer PVC will be about 6 million tons in 2020 (Brown et al., 2000, Economic evaluation of PVC
waste management, report produced for the European Commission)
Current European production of PVC is about 8 million tons per year including exports (www.pvc.org)
Current European consumption is about 6.5 million tons per year (www.pvc.org)
Exposure scenarios for the formulation of recycled soft PVC containing DEHP in compounds and dry blends
and for the industrial use of recycled soft PVC containing DEHP in polymer processing by calendering,
extrusion, compression and injection moulding to produce PVC articles, may vary widely depending on the
specific processes that are used, on the particular tasks that are carried out and on the concrete working
conditions in place in each factory.
Exposure ambient concentrations of DEHP between 0,5 and 5 mg/m 3 have been measured, and DEHP has
been bio-monitored in worker urine samples (122-5379,7 MEHP μg/g urinary creatinine) at multiple PVC
working sites, showing a varying but clear occupational exposure to DEHP from these uses (see attached
article from INRS).
Without knowing the specific conditions of use of DEHP at each site and the different processes and tasks
involved, it is not possible to assess the workers risk of exposure to this SVHC, and therefore it is not
possible to determine if they are adequately controlled.
As described in the attached document the application lacks the specific information needed to demonstrate
that all the risks derived from the uses of DEHP applied for may be adequately controlled (see attached
document with EEB comments on the submitted exposure scenario).
Regarding the consumers exposure, the applicant assumes that the risks are also adequately controlled.
However, there are plenty of studies that show that consumers’ exposure to relatively common levels of
DEHP in PVC consumer products is linked to very concerning effects.
For example, the study: Toft, G, BAG Jönsson, CH Lindh, TK Jensen, NH Hjollund, A Vested and JP Bonde.
2011. Association between pregnancy loss and urinary phthalate levels around the time of conception.
Environmental Health Perspectives http://dx.doi.org/10.1289/ehp.1103552, shows that women exposed near
the time of conception to relatively common levels of a particular phthalate are more likely to experience
early pregnancy loss compared to women with lower exposures.
From 1992 to 1994, couples in Denmark trying to get pregnant for the first time participated in the study by
donating daily urine samples. In 2009, researchers analyzed the samples for levels of a hormone called hCG
(human chorionic gonadotropin), which is the same hormone that home pregnancy tests can detect.
Of the 148 women followed, 48 had a pregnancy loss, of which 32 were early on and identified by fluctuating
hCG hormone levels. The women in this study were exposed to phthalates at the same levels as women in
other parts of the world, such as Germany and the United States.
High levels of MEHP indicate a greater exposure to the particular phthalate di-(2 ethylhexyl)phthalate
(DEHP), which is a component in plastics.
Another study (http://www.sciencedirect.com/science/article/pii/S0378427411016559) has shown urinary
phthalate monoesters concentration in couples with infertility problems.
Another report (http://chej.org/wp-content/uploads/HiddenHazardsReportFINAL.pdf) finds toxic levels of
phthalates lurking in popular back-to-school items.
There also many studies that show phthalates in PVC floors taken up by the body in infants, such as a study
performed
by
Karlstad
University
in
Sweden
(http://www.sciencedaily.com/releases/2012/05/120523102142.htm)
Therefore consumer exposure to DEHP contained in PVC plastic products is clearly not adequately
controlled either.
The scope of the application is too general
The applicant is asking for a broad authorization that covers all uses of DEHP in recycled soft PVC. This is
against REACH Regulation as authorisations should be use specific.
Mixture toxicity of phthalates is disregarded
The application does not take into account additive effects of DEHP with other phthalates that also present in
recycled soft PVC. Mixture toxicity of DEHP has been well described in scientific literature. This is very
concerning since adequate control should be proven in a holistic manner.
The application should follow the socio economic authorization route
According to REACH article 60(3a), the adequate control route shall not apply for substances meeting the
criteria in CMR or article 57(f) for which it is not possible to determine a threshold in accordance with Section
6.4 of Annex I.
DEHP is a known EDC. Due to the importance of timing of exposure, mixture toxicity, non-linear dose
response relationships, etc., the uncertainties in the risk assessment make it very doubtful that safe
thresholds can be derived with sufficient certainty for DEHP.
Review period
Authorisation should not be granted for DEHP use in recycled soft PVC articles. However if it is finally
granted, the review period should be as short as possible due to the availability and suitability of safer
alternatives in the market.
REFERENCES

http://www.healthybuilding.net/pvc/alternatives.html

TURI: "Five Chemicals Alternatives Assessment Study" report, Chapter 7, "DEHP" (AVAILABLE AT:
http://www.turi.org/TURI_Publications/TURI_Methods_Policy_Reports/Five_Chemicals_Alternatives
_Assessment_Study._2006)

http://www.cbcflooring.com/ceres/index.html

Healthy & Sustainable Flooring, choosing resilient flooring for the European healthcare sector
(available at: http://www.noharm.org/lib/downloads/chemicals/2012_Flooring_report_dp.pdf)

http://www.greenpeace.org/international/en/Guide-to-Greener-Electronics/18th-Edition/

http://www.dell.com/learn/us/en/uscorp1/corp-comm/earth-greener-products-materials

AMEC Analysis of alternatives for a group of phthalates. Final Report. RIVM - Dutch National
Institute for Public Health and the Environment. 2013 (attached as ‘Analysis of alternatives for a
group of phthalates - AMEC final report’)

Green Chemistry and Commerce Council Consortium report (See:
http://www.greenchemistryandcommerce.org/documents/PilotProjectFullReportOct2-final_000.pdf.
See overview of the project at:
http://www.greenchemistryandcommerce.org/documents/BusinessandAcademicPartnershipsforSafer
Chemicals-RT2013.pdf)

HDP'S analysis of halogen free cables project.
http://www.pcbdesign007.com/pages/zone.cgi?artcatid=0&a=80209&artpg=1&artid=80209&pg=1

http://www.alibaba.com/showroom/pvc-free-waterproof-fabric.html

Healthy Business Strategies for Transforming the Toxic Chemical Economy. Clean Production
Action. (Attached as ‘CPA_Bus_Strategies_26jun06_FINAL’)

Healthy Business Strategies for Transforming the Toxic Chemical Economy. Clean Production
Action. (Attached as ‘CPA_Bus_Strategies_26jun06_FINAL’)

Kruopiene, J. et al. Use and Substitution of DEHP in Lithuanian Furniture Industry. Environmental
Research Engineering and Management, 2004, 4 (30), 61-65.

http://www.healthystuff.org/documents/2012_Cars.pdf

Analysis of alternatives for a group of phthalates, Final Report. RIVM - Dutch National Institute for
Public Health and the Environment & AMEC Environment & Infrastructure UK Limited. December
2013.

“Product design screening method helps reduce toxic materials in consumer goods”. European
Commission (available at:
http://ec.europa.eu/environment/integration/research/newsalert/pdf/323na6.pdf)

“Environmentally Friendly Plastics”. In a new study, researchers from the University of Minnesota
have developed a portfolio of degradable plastics derived from renewable resources that could serve
as a viable alternative to plastics made from petroleum and natural gas. Marc Hillmyer, Distinguished
McKnight University Professor of chemistry and director of the Centre for Sustainable Polymers in
the College of Science and Engineering. Environmental Protection News, 26 April 2011
http://www.eponline.com

Brown et al., 2000, Economic evaluation of PVC waste management, report produced for the
European Commission

www.pvc.org

Toft, G, BAG Jönsson, CH Lindh, TK Jensen, NH Hjollund, A Vested and JP Bonde. 2011.
Environmental Health Perspectives http://dx.doi.org/10.1289/ehp.1103552

study (http://www.sciencedirect.com/science/article/pii/S0378427411016559)

report (http://chej.org/wp-content/uploads/HiddenHazardsReportFINAL.pdf)

Karlstad University in Sweden (http://www.sciencedaily.com/releases/2012/05/120523102142.htm)
SUBSPORT:

Substitution of PVC floorings (available at: http://www.subsport.eu/case-stories/123-en?lang=)

An alternative to phthalates: Novel plastic softener produced from castor oil and acetic acid
(available at: http://www.subsport.eu/case-stories/205-en?lang=)

Proactively eliminating the phthalates DEHP, BBP, DBP and DIBP from electronic products
(available at: http://www.subsport.eu/case-stories/304-en?lang=)

Polyvinyl chloride (PVC) Power Cord Alternatives (available at: http://www.subsport.eu/casestories/114-en?lang=)

Cables without lead, PVC and phthalates (available at: http://www.subsport.eu/case-stories/039en?lang=)

Substitution of phthalates in textile print applications (available at: http://www.subsport.eu/casestories/377-en?lang=)

Substitution of phthalates from childrenswear prints (available at: http://www.subsport.eu/casestories/373-en?lang=)

An alternative to PVC and phthalates in high density plastisol prints (available at:
http://www.subsport.eu/case-stories/371-en?lang=)
APPENDIXES
I.
R. Gaudin, P. Marsan, S. Ndaw, A. Robert. Surveillance biologique de l’exposition au phtalate de
di-(2-éthylhexyle) (DEHP) dans six entreprises françaises. INRS, RÉFÉRENCES EN SANTÉ AU
TRAVAIL. N° 133.Mars, 2013.
Gaudin_et_al_INRS.
pdf
II. European Environmental Bureau comments on the non-confidential version of exposure scenarios
submitted by application 0002-01, 0002-02, 0003-01, 0003-02, 0004-01, 0004-02
EEB_ES_comments_P
VC_recycling.pdf
III. AMEC Analysis of alternatives for a group of phthalates. Final Report. RIVM - Dutch National
Institute for Public Health and the Environment. 2013
Analysis of
alternatives for a group of phthalates - AMEC final report.pdf
IV. Healthy Business Strategies for Transforming the Toxic Chemical Economy. Clean Production
Action. (Attached as ‘CPA_Bus_Strategies_26jun06_FINAL’)
CPA_Bus_Strategies
_26jun06_FINAL.pdf