Communication from the Commission on the results of the risk evaluation and the risk reduction strategies for the substances: benzyl butyl phthalate (BBP), 2-furaldehyde (furfural), perboric acid, sodium salt (Text with EEA relevance)
Date: 2008-06-14
Institutions: European Commission
Subjects: acid, chemical salt, dangerous substance, environmental impact, health control, health risk, occupational safety, organic chemical, toxicology

C 149/14

EN

Official Journal of the European Union

14.6.2008

Communication from the Commission on the results of the risk evaluation and the risk reduction
strategies for the substances: benzyl butyl phthalate (BBP), 2-furaldehyde (furfural), perboric acid,
sodium salt

(Text with EEA relevance)

(2008/C 149/04)

Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of
existing substances (1) involves the data reporting, priority setting, risk evaluation and, where necessary,
development of strategies for limiting the risks of existing substances.

In the framework of Regulation (EEC) No 793/93 the following substances have been identified as priority
substances for evaluation in accordance with Commission Regulations (EC) No 2268/95 (2) and (EC)
No 143/97 (3) respectively concerning the second and third list of priority substances as foreseen under
Regulation (EEC) No 793/93:

— benzyl butyl phthalate (BBP),

— 2-furaldehyde (furfural),

— perboric acid, sodium salt.

The rapporteur Member States designated pursuant to those Regulations have completed the risk evaluation
activities with regard to man and the environment for those substances in accordance with Commission
Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man
and the environment of existing substances (4) and have suggested a strategy for limiting the risks in accord-
ance with Regulation (EEC) No 793/93.

The Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) and the Scientific Committee
on Health and Environmental Risks (SCHER) have been consulted and have issued an opinion with respect
to the risk evaluations carried out by the rapporteurs. These opinions can be found on the website of the
Scientific Committees.

Article 11(2) of Regulation (EEC) No 793/93 stipulates that the results of the risk evaluation and the recom-
mended strategy for limiting the risks shall be adopted at Community level and published by the Commis-
sion.
corresponding Commission Recommendation
the
2008/447/EC (5), provides the results of risk evaluations (6) and strategies for limiting the risks for the above
mentioned substances.

This Communication,

together with

The results of the risk evaluation and strategies for limiting the risks provided for in this communication
are in accordance with the opinion of the Committee set up pursuant to Article 15(1) of Regulation (EEC)
No 793/93.

(1) OJ L 84, 5.4.1993, p. 1.
(2) OJ L 231, 28.9.1995, p. 18.
(3) OJ L 25, 28.1.1997, p. 13.
(4) OJ L 161, 29.6.1994, p. 3
(5) OJ L 156, 14.6.2008.
(6) The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the Internet site of the

European Chemicals Bureau:
http://ecb.jrc.it/existing-substances/

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C 149/15

ANNEX

PART 1

CAS No: 85-68-7

Einecs No: 201-622-7

Structural formula:

Einecs name:

IUPAC name:

Rapporteur:

Classification (1):

Benzyl Butyl Phthalate

Benzyl Butyl Phthalate

Norway

Repr. Cat. 2; R61

Repr. Cat. 3; R62

N; R50-53

The risk assessment is based on current practices related to the life-cycle of the substance produced in or imported into
the European Community as described in the risk assessment forwarded to the Commission by the Member State
Rapporteur (2).

The risk assessment has, based on the available information, determined that in the European Community the substance
is mainly used (more than 95 %) as a plasticizer of polyvinyl chloride (PVC) or other polymers.

The BBP-plasticized polymeric material has consumer and industrial uses such as in flooring, sealants, paints, textile
coating and adhesives. A minor use is in a non-polymeric application and a relatively small but significant use is in the
food wrap or food packaging area which has diminished over recent years due to technological developments leading to
no further requirement for BBP in one of the food wrap applications (i.e. regenerated cellulose film). Furthermore, BBP
has been reported at low concentrations in child-care articles and children's toys; however, in these products BBP probably
occurs as by-products/impurities and has not been added intentionally to the products.

Because BBP is not chemically bound to the matrix it can migrate from the polymeric material and become available for
emissions to other matrices (environmental or biological). BBP can be released from polymer-based products during their
use or after disposal. The rate of emission is dependent on various factors, for example temperature and physical or
mechanical handling of the product.

RISK ASSESSMENT

A. Human health

The conclusion of the assessment of the risks to

WORKERS, CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

It should be noted that additive effects related to co-exposure with other phthalates has not been evaluated in the risk
assessment.

(1) Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the 29th time Council Directive 67/548/EEC
on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of
dangerous substances (OJ L 152, 30.4.2004, p. 1, amended by OJ L 216, 16.6.2004, p. 125).

(2) The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet site of the European Chemicals

Bureau:
http://ecb.jrc.it/existing-substances/

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14.6.2008

The conclusion of the assessment of the risks to

HUMAN HEALTH (physico-chemical properties)

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

B. Environment

The conclusion of the assessment of the risks to the

ATMOSPHERE

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to the

AQUATIC ECOSYSTEM

1.

is that there is a need for further information and/or testing. This conclusion is reached because:

— there is a need for better information to adequately characterise the risks to the aquatic ecosystem.

The information and/or test requirements are

— a long-term fish study on reproductive and endocrine effects;

2.

is that there is a need for specific measures to limit the risks. Risk reduction measures which are already being applied
shall be taken into account. The conclusion is reached because of:

concerns for the aquatic compartment (including sediment) as a consequence of exposure arising from flooring at
large and small sites and non polymer use during processing and formulation.

The conclusion of the assessment of the risks to the

TERRESTRIAL ECOSYSTEM

is that there is a need for specific measures to limit the risks. Risk reduction measures which are already being applied
shall be taken into account. The conclusion is reached because of:

— concerns for the terrestrial compartment (including sediment) as a consequence of exposure arising from flooring at
large and small sites, PVC coated textiles and non polymer use during processing and formulation. The scenarios that
give concern are generic scenarios based on default emission data.

The conclusion of the assessment of the risks to

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

For WORKERS

STRATEGY FOR LIMITING RISKS

The legislation for workers protections currently in force at Community level is generally considered to give an adequate
framework to limit risks of the substance to the extent needed and shall apply. Within the framework it is recommended:

— to establish at community level occupational exposure limit values for BBP according to Directive 98/24/EC ( 1).

For ENVIRONMENT

It is recommended

— in order to facilitate permitting and monitoring under Council Directive 2008/1/EC ( 2) (Integrated Pollution Prevention
and Control) that BBP should be included in the ongoing work to develop guidance on ‘Best Available Techniques’
(BAT),

(1) OJ L 131, 5.5.1998, p. 11.
(2) OJ L 24, 29.1.2008, p. 8.

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— to consider, within the framework of existing legislative measures under Council Directive 76/769/EEC (Marketing and
Use Directive), restrictions for the use of BBP in industrial installations for processing polymers with BBP (formulation
and processing of plastisol flooring) and formulation and processing of PVC coated textiles and non polymer uses
with BBP, exempting installations with no emission of BBP to the environment as well as installations where BBP emis-
sions are adequately controlled. Adequate control could e.g. be achieved through efficient treatment of exhaust air and
aqueous effluents. The efficiency in emissions' reduction should be documented to enable follow up by Member State
authorities.

PART 2

Einecs No: 202-627-7

CAS No: 98-01-1

Structural formula:

Molecular formula:

Einecs name:

IUPAC name:

Rapporteur:

Classification (1):

C5H4O2
2-furaldehyde

2-furaldehyde

Netherlands

None

The risk assessment is based on current practices related to the life-cycle of the substance produced in or imported into
the European Community as described in the risk assessment forwarded to the Commission by the Member State
Rapporteur.

The risk assessment has, based on the available information, determined that in the European Community the substance
is used for about 75 % in the production of furan derivates. The remaining part is mainly used as a selective solvent in
refineries. Other reported uses are in manufacturing refractories and pesticides, or use as a chemical tracer in gas-oil (refi-
neries). Furthermore it is used as fragrances in cosmetics, and as a reagent in analytical chemistry. For the UK a different
use pattern is present, where approximately 40 % is used in the production of resins, abrasive wheels and refractories.

In addition the risk assessment has identified unintentional sources of exposure which do not result from the life-cycle of
the substance produced in or imported into the European Community. In particular, 2-furaldehyde is a natural volatile
compound identified in many foods (fruits, vegetables, wine, bread) and in several essential oils of plants; 2-furaldehyde is
formed in trace amounts in a number of dietary sources and as a degradation by-product in the refuse of chemical and
fuel production. 2-furaldehyde is also a major contaminant from the sulfite pulping processes used in pulp and paper
industry, or may be released to the environment via the smoke from burning wood. The risks arising from these uninten-
tional exposures are beyond the scope of this comprehensive Risk Assessment Report, which does however provide infor-
mation that can be used to assess those risks.

RISK ASSESSMENT

A. Human health

The conclusion of the assessment of the risks to

WORKERS

is that there is a need for specific measures to limit the risks. This conclusion is reached because of:

— concerns for systemic effects and local effects on respiratory tract as a consequence of exposure arising from repeated

inhalation exposure in all scenarios,

— concerns for systemic effects as a consequence of exposure arising from repeated dermal exposure in cleaning and

maintenance during production,

— concerns for developmental effects as a consequence of exposure arising from repeated dermal and inhalation expo-

sure in cleaning and maintenance during production,

— concerns for carcinogenicity as a consequence of exposure arising from repeated dermal and inhalation exposure in all

exposure scenarios.

(1) This chemical substance is currently not included in the Annex I of Directive 67/548/EEC.

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The conclusion of the assessment of the risks to

CONSUMERS

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to

HUMANS EXPOSED VIA THE ENVIRONMENT

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to

HUMAN HEALTH (physico-chemical properties)

is that there is at present no need for further information and/or testing or for risk reduction measures. This conclusion is
reached because:

— given the intrinsic properties of the substance, risks from physicochemical properties are not expected.

B. Environment

The conclusion of the assessment of the risks to the

ATMOSPHERE

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to the

TERRESTRIAL ECOSYSTEM

is that there is a need for further information and/or testing. This conclusion is reached because:

— there is a need for better information to adequately characterise the toxic effects of 2-furaldehyde to the terrestrial
ecosystems. The PECsoil exceeds the PNECsoil in the scenarios ‘formulation for manufacturing refractories’ and ‘use as
intermediate in pesticide manufacture’. The terrestrial PNEC is derived through the equilibrium partitioning method
and there is therefore scope to refine this PNEC through testing,

— however, no testing is proposed for the terrestrial compartment since risk reduction measures are proposed for the

local aquatic compartment which should cover the conclusions for the terrestrial compartment.

The conclusion of the assessment of the risks to the

AQUATIC ECOSYSTEM

is that there is a need for specific measures to limit the risks. This conclusion is reached because of:

— concerns for the aquatic compartment as a consequence of exposure arising from formulation of chemical tracer in
mineral oil and fuel industry, formulation for manufacturing refractories and use as intermediate in pesticide manufac-
ture.

The conclusion of the assessment of the risks to

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

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For WORKERS

STRATEGY FOR LIMITING RISKS

The legislation for workers' protection currently in force at Community level is generally considered to give an adequate
framework to limit the risks of the substance to workers to the extent needed and shall apply.

Within this framework it is recommended:

— to establish at community level occupational exposure limit values for 2-furaldehyde according to Directive

98/24/EEC (1).

For ENVIRONMENT

— it is recommended in order to facilitate permitting and monitoring under Directive 2008/1/EC ( 2) (Integrated Pollution
Prevention and Control) that 2-furaldehyde should be included in the ongoing work to develop guidance on ‘Best
Available Techniques’ (BAT).

PART 3

CAS No: 11138-47-9

Einecs No: 234-390-0

Number for the anhydrous form which covers the mono- and tetrahydrate

Structural formulas:

BHO3 · H2O · Na (monohydrate)

Einecs name:

IUPAC name:

Rapporteur:

Classification (3):

BHO3 · 4H2O · Na (tetrahydrate)

Perboric acid, sodium salt

Sodium perborate

Austria

None

The risk assessment (4) is based on current practices related to the lifecycle of the substance produced in or imported into
the European Community as described in the comprehensive Risk Assessment Report forwarded to the Commission by
the Member State Rapporteur.

The risk assessment assesses the risk arising from sodium perborate and its degradation product, hydrogen peroxide. The
risk of the degradation product boric acid has not been assessed in the comprehensive Risk Assessment Report.

The risk assessment has, based on the available information, determined that in the European Community sodium perbo-
rate mono- and tetrahydrate are mainly used as oxidizing and bleaching agents in detergents (household detergents as well
as detergents for institutional uses) and also in cleaning (e.g. automatic dishwashers, stain removers in form of bleach
booster tablets) and cosmetic preparations (denture cleansers). In laundry washing applications, perborates are used in
regular and compact heavy-duty powders.

RISK ASSESSMENT

A. Human health

The conclusion of the assessment of the risks to

WORKERS

is that there is a need for specific measures to limit the risks. This conclusion is reached because of:

— concerns for local effects on the upper airways and for developmental effects as a consequence of inhalation exposure

in the production of sodium perborate.

(1) OJ L 131, 5.5.1998, p. 11.
(2) OJ L 24, 29.1.2008, p. 8.
(3) This chemical substance is currently not included in the Annex I of Directive 67/548/EEC.
(4) The comprehensive Risk Assessment Report, as well as a summary thereof, can be found on the internet site of the European Chemicals

Bureau:
http://ecb.jrc.it/existing-substances/

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The conclusion of the assessment of the risks to

CONSUMERS and HUMANS EXPOSED VIA THE ENVIRONMENT

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to

HUMAN HEALTH (physico-chemical properties)

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

B. Environment

The conclusion of the assessment of the risks to the

ATMOSPHERE, AQUATIC ECOSYSTEM, and TERRESTRIAL ECOSYSTEM:

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

The conclusion of the assessment of the risks to

MICRO-ORGANISMS IN THE SEWAGE TREATMENT PLANT

is that there is at present no need for further information and/or testing or for risk reduction measures beyond those
which are being applied. This conclusion is reached because:

— the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered

sufficient.

For WORKERS

STRATEGY FOR LIMITING RISKS

The legislation for workers' protection currently into force at Community level is generally considered to give an adequate
framework to limit the risks of the substance to the extent needed and shall apply.