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UQ
Ultra Química
Especialidades Químicas, Lda.
Talaíde Park
Armazém 9 – Edificio A
Estrada Octávio Pato – Talaíde
2785-601 São Domingos de Rana
(Lisboa) / PORTUGAL
Tel:
+351-21-423 1567
Fax:
+351-21-423 1569
E-mail: [email protected]
Introduction of PARABENS
Parabens (esters of para-benzoic acid) are widely used as food additives and synthetic preservatives
in cosmetics and personal care products, and in pharmaceutical formulations. Common types include
methyl paraben, ethyl paraben and propyl paraben.
Parabens are the most vital ingredients in Pharmaceutical Formulations & Cosmetic
Products. They have been in use since 1924 for the last many decades due to its harmless
properties. Their applications in Pharmaceuticals & Cosmetic Industry have been tried and
tested and have been certified as totally harmless to Human Life by various Medical
Universities. Parabens when used in combination with other compounds is very helpful in
formulations of Cosmetics and are used in very low levels of 0.01 to 0.03%.
Parabens have been recommended to be used in all formulations in the range of 0.1 to 0.5%.
This in turn enhances the shelf life of Products quite substantially without changing their
chemical properties. Considering the very small quantity of Parabens being used and the
extension of shelf life of final formulated Products being quite substantial indicates the
importance of usage of Parabens in Pharmaceuticals & Cosmetic Industries.
Parabens are a group of chemicals commonly known by other names like Esters of PHydroxy Benzoic Acid. They are Non Toxic and recognized as suitable for use in Food
Ingredients without any Toxic effects. They are found to be very effective at low
concentrations and are used as Broad Spectrum Anti Microbial Agents. Their toxicological
studies have been approved by National Toxicology Centre, Pune, Maharashtra (INDIA).
These are also found to be very useful against Mold & Yeast and find wide applications in
Food Industry. The expert panel of the Cosmetic Ingredients Review (CIR) has concluded
usage of Parabens as safe in Cosmetics, Foods and Pharmaceutical Industries. They are
also used as Preservatives in various Drug Formulations from Microbial Organisms.
Parabens are certified as safe under United States – Food & Drug Administration Regulation
(US-FDA) and recommended for usage as Preservatives by European Pharmacopeia in
Foods, Cosmetics and Pharmaceuticals Industries. Their Toxic effects are found to be below
permissible levels and are well certified by leading Health Organizations such as World
Health Organization (WHO) and Star K-Kosher, Baltimore, Maryland-USA.
Parabens are known to have varied applications in different Product Categories as
under:
1. They are safely used as BIOCIDES in Cosmetics such as Creams, Lotions, Face Wash
and various types of Anti Fungal Creams.
2. In Food Industries, Parabens are used as BIOCIDES for various types of processed
vegetables, Baked Foods, Fats & Oils, Seasonings, Sugar substitutes and Frozen Dairy
Products in the concentrations upto 0.1%.
3. Parabens are widely used as BIOCIDES in various Pharmaceutical Formulations and are
certified to be more effective than individual esters.
UQ
Ultra Química
Especialidades Químicas, Lda.
Talaíde Park
Armazém 9 – Edificio A
Estrada Octávio Pato – Talaíde
2785-601 São Domingos de Rana
(Lisboa) / PORTUGAL
Tel:
+351-21-423 1567
Fax:
+351-21-423 1569
E-mail: [email protected]
4. Parabens are also widely used as BIOCIDES in Poultry Industry in the manufacture of
various types of Vaccines.
5. The SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS (SCCP) of European
Commission has in the light of the present knowledge certified the use of Parabens as risk
free for the development of Breast Cancer.
Considering the above varied applications of Parabens, it can be concluded that the usage of
Parabens is very safe as BIOCIDES in Pharmaceuticals, and other types of Industries as
recommended by various Health Authorities like WORLD HEALTH ORGANISATION (WHO),
FOOD & DRUG ADMINISTRATION (FDA) and the SCIENTIFIC COMMITTEE ON
CONSUMER PRODUCTS (SCCP) of European Commission.
The global market for Parabens is around 8000-10000 MT per annum while the Indian
market is around 600 MT per annum. This requirement is growing annually at the rate of 56% globally.
PARABENS : OTHER USES
1). The maximum permitted concentration for Parabens in European Union is 0.4%.
2). Parabens are used in various drug formulations as BIOCIDES from microbial organisms.
3). The Parabens are also used as BIOCIDES in the preservation of Animal tissues, face
lotions, oral medicines, emulsions, shaving lotions, soaps, Tooth paste, Talcum Powder,
Starch solution and API drug formulations from microbial organisms. The maximum
permitted usage level is in the range of 0.1 to 0.4%.
SINGLE PARABEN APPLICATION
Products :
Methyl Paraben, Propyl Paraben, Butyl Paraben, Ethyl Paraben, Sodium Methyl Paraben,
Sodium Propyl Paraben , Sodium Butyl Paraben, Sodium Ethyl Paraben
Applications with Usage Levels
Usage levels : 0.1 to 0.3% (Max. up to 0.4%)
Applications : Pharmaceutical, food, Personal Care products and Cosmetic Industries.
Regulatory Status for cosmetic ingredients:.
United States : 0.1 to 0.3% (Max. up to 0.4%)
European Union & Brazil : 0.4 to 0.8%
MICROBACTERIAL EFFECTS OF PARABENS
Minimum Inhibitory Concentration of Parabens (%)
Microorganism
1. Bacteria
• Bacillus Subtilis :
Methyl Paraben : 0.2 %
Butyl Paraben : 0.0125 %
UQ
Ultra Química
Especialidades Químicas, Lda.
Talaíde Park
Armazém 9 – Edificio A
Estrada Octávio Pato – Talaíde
2785-601 São Domingos de Rana
(Lisboa) / PORTUGAL
Tel:
+351-21-423 1567
Fax:
+351-21-423 1569
E-mail: [email protected]
Ethyl Paraben : 0.1 %
Propyl Paraben : 0.025 %
• Bacillus Cereus var. mycoides :
Methyl Paraben : 0.2 %
Butyl Paraben : 0.0063 %
Ethyl Paraben : 0.1 %
Propyl Paraben : 0.0125 %
2. Molds
• Aspergillus niger:
Methyl Paraben : 0.1 %
Butyl Paraben : 0.02 %
Ethyl Paraben : 0.04 %
Propyl Paraben : 0.02 %
• Penicillium digitatum:
Methyl Paraben : 0.05 %
Butyl Paraben : 0.0032 %
Ethyl Paraben : 0.025 %
Propyl Paraben : 0.0063 %
3. Yeasts
• Candida Albicans :
Methyl Paraben : 0.1 %
Butyl Paraben : 0.0125 %
Ethyl Paraben : 0.1 %
Propyl Paraben : 0.0125 %
• Saccharomyces Cerevisiae:
Methyl Paraben : 0.1 %
Butyl Paraben : 0.0063 %
Ethyl Paraben : 0.05 %
Propyl Paraben : 0.0125 %
Methylparaben:
Items
Appearance
Purity (on dry base)
Melting points
Residue on ignition
Acidity
Apperance of solution
Related substance
Heavy metals (Pb)
Organic volatile impurities
Identification
Standards
White powder
99.0-100.5%
125-128
≤0.1%
Passed
Passed
Passed
≤10ppm
Passed
Passed
UQ
Ultra Química
Especialidades Químicas, Lda.
Talaíde Park
Armazém 9 – Edificio A
Estrada Octávio Pato – Talaíde
2785-601 São Domingos de Rana
(Lisboa) / PORTUGAL
Tel:
+351-21-423 1567
Fax:
+351-21-423 1569
E-mail: [email protected]
Propylparaben:
Items
Appearance
Purity (on dry base)
Melting points
Residue on ignition
Acidity
Apperance of solution
Related substance
Heavy metals (Pb)
Standards
White crystalline powder
99.0-100.5%
96-99
≤0.1%
Passed
Passed
Passed
≤10ppm