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Evaluation of Alternatives for Compounds under Risk Assessment in the EU, Bisphenol A
8 Evaluation of the possible alternatives to bisphenol A
During the project period no specific substance was pointed out by the industry as an alternative to bisphenol A in coated food or beverage containers, polycarbonates, thermographic
printing, toners or printing inks. However, several possible alternatives or groups of substances were mentioned and investigated.
The evaluation of the possible alternatives was based on the internationally accepted principles for classification of single substances, i.e. risk phrases (R-phrases). A large number of
chemicals have been officially classified on the basis of their potential toxicity to human health whereas only very few of these chemicals have been classified for their potential hazardous
environmental effects. But due to the implementation of Directive 1999/45/EC of the European Parliament and of the Council, preparations of chemicals must now be evaluated and
classified with respect to both human health and to the environment.
The environmental and health properties of a substance are dependent on the inherent properties of the specific substance. Therefore, the environmental and health properties can vary
within a group of substances, i.e. a detailed risk assessment of e.g. a polyacrylate will require specific data on that specific substance. An environmental and health screening based on
the general properties of a chemical group or based on a single substance of a chemical group may, however, be used to indicate the potential hazards of the alternative substance to the
environment and human health.
A summary of the results of the environmental and health hazard assessment of possible alternatives to bisphenol A in coatings, polycarbonates and printing inks is given in Table 8.1.
Furthermore, the EU environmental and health assessment of BPA is given for comparison (EU, 2003A).
Bisphenol A is considered to be readily biodegradable and not bioaccumulative but toxic to aquatic organisms. It does thus not fulfil the criteria for classification as regards the
environment but further discussion is needed as the observed effects at low concentrations of bisphenol A in long-term toxicity studies justify the application of suitable risk and safety
phrases (EU, 2003A).
From an environmental point of view the alternative polyester and polyamide, depending on the specific substances, may turn out to cause less harmful effects than BPA whereas
polymerised rosin and monomers from polyacrylates may cause the same or more hazardous effects on the environment as bisphenol A.
From the health point of view the possible alternatives, polyesters and polyamides depending on the specific substances, may turn out to cause less harmful effects than BPA, whereas
some polyacrylates may be irritating to eyes, respiratory system and skin and polymerised rosins may cause sensitisation by skin contact. Bisphenol A is known to be irritating to
respiratory system, cause risk of serious damage to eyes and sensitisation by skin contact.
Furthermore, bisphenol A is on the list of substances, which are suspected as endocrine disrupters, and it has been suggested to classify it with R62 (possible risk of impaired fertility)
(EU, 2003A). None of the mentioned alternatives are on this list but it should be mentioned that potential endocrine disrupting effects have most likely not been examined for the
alternatives.
The environmental and health effect of the alternative will, however, totally depend on the specific chemical compound in focus including possible migration of monomers etc. and the
assessment should be revised on the basis of the properties of the specific chemical compound.
Table 8.1 Screening of environmental and health properties of the possible alternatives to bisphenol A
Focus area |
Name of alternative |
Environmental
assessment
|
Health
assessment
|
Endocrine disruption1 |
Coating |
Polyacrylates
(possible migration of
monomers)
|
The polymers: not officially classified.
Acrylate monomers: N;R51/53
|
The polymers: not classified.
Monoalkyl or monoaryl or monoalkylaryl esters
of acrylic acid: Xi;R36/37/38
|
No |
Coating |
Polyester
(63148-69-6)
|
Not officially classified |
The polymers: not classified |
No |
Polycarbonate |
Polyamides
Grilamid TR.
Polyamide (nylon)
Nylon 66 (hexamethylene
adipamide)
(32131-17-2)
(3323-53-3)
|
Not officially classified: The available data indicate that the substance
should not be classified as hazardous to the environment. |
The polymers: not classified |
No |
Printing inks |
Polyacrylates
(possible migration of
monomers)
|
The polymers: Not officially classified.
Acrylate monomers: N;R51/53
|
The polymers: not classified.
Monoalkyl or monoaryl or monoalkylaryl esters
of acrylic acid: Xi;R36/37/38
|
No |
Printing inks |
Polymerised rosin
(8050-09-7)
|
Not officially classified: Possible classification:
N;R50/53
|
Xi;R43 (N-Class, 2003) |
No |
All areas |
Bisphenol A
(80-05-7)
|
BPA does not fulfil the criteria for classification (EU, 2003A). |
Xi; R36/37/38 R43 (Danish EPA, 2002).
Suggestion:
Repr. Cat. 3; R62
Xi; R37-41, R43 (EU, 2003A)
|
Yes |
1) List of substances, which are or are potential endocrine disrupting (Danish EPA, 2003)
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Version 1.0 March 2004, © Danish Environmental Protection Agency
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