Germany: Federal Office of Consumer Protection and Food
Safety (BVL) Publishes Up-to-date Overview of Technically
Preventable Contents of Heavy Metals in Cosmetic Products
The substances listed in Annex II of the Cosmetics Regulation (EC) No.
1223/2009 are prohibited in cosmetic products. Heavy metals such as
Lead, Cadmium, Arsenic and Antimony and their compounds are
included therein, as well as Mercury and its compounds, in case they are
not used as preservatives. The unintentional presence of small quantities,
which can originate from impurities, production process or migration from
the packaging and are technically unavoidable, even in good
manufacturing practice, Article 17 of the Regulation permits if the safety
of the product in normal or reasonably foreseeable use is still ensured.
Manufacturers of cosmetic products should develop their products according to the
precautionary principle and comply with their due diligence towards the consumers. Heavy
metals are often passed into the product via contaminated raw materials and are not
specifically added to it. Especially these substances are harmful to health or toxic to the
human organism because they cannot be disintegrated.
In 1985 the Federal Health Office (BGA) already recommended technically avoidable
contents of heavy metals for finished cosmetic products.1 In the meantime, these values
are outdated and have been adapted to the current state of the art.
Often increased heavy metal contents are found in powder and cream products, decorative
cosmetics and toothpastes, because these products contain high percentage of inorganic
or mineral components. However, heavy metals are only permitted if they´re removed from
the cosmetic compositions completely or as far as possible in such a way, that the residuals
therein are present as technically unavoidable or technologically ineffective amounts that
are harmless to health.
During a monitoring in the years 2010 to 2012, the BVL (Federal Office of Consumer
Protection and Food Safety) determined the contents of lead, cadmium, mercury, arsenic
and antimony in 1.735 samples of product groups as baby powder, lipstick, lip blush, lip
powder, lip contour pencil, mascara, eyeliner, eye shadow, make up, tinting cream,
camouflage, rouge, theater-, fan- and carnival make-up, toothpaste and children's
toothpaste according to the standard method of digestion.2
Table 1:
In the future, the following heavy metal contents in cosmetic products
are considered to be technically avoidable
Element
Lead (Pb)
Cosmetic products
in general [mg/kg]
2,0 a
Toothpaste
[mg/kg]
0,5
Cadmium (Cd)
0,1
0,1
Mercury (Hg)
0,1
0,1
Arsenic (As)
Antimony (Sb)
a
0,5
b
0,5
0,5
0,5
For the product groups make-up-powder, rouge, eye shadow, eyeliner, kajal as well as theater, fan
and carnival make up: 5 mg / kg
b
For theater, fan and carnival make up: 2.5 mg / kg
The results of the BVL analysis showed that in the meanwhile the values of BGA guideline
are often below the technical unavoidability and are no longer up-to-date.
Therefore a new calculation of the statistical key figures, reflecting the new limit values (see
table 1), was carried out.
If traces of one of these heavy metals exceed the values mentioned in table 1, the safety
report of the cosmetic product has to consider this and provide the evidence that those
amounts are safe for the consumer.
In addition the BfR (Federal Institute for Risk Assessment) recommends to regulate the
heavy metal contents based on the purity of the respective raw materials (table 2).
Table 2:
Purity requirements of the raw materials (dyestuffs) for the
manufacture of cosmetic products
Element
Lead
Cadmium, Mercury, Selenium, Tellurium, Thallium, Uranium,
Chromate and Barium compounds soluble in hydrochloric
acid
Zinc, Barium sulfate as sum
Arsenic
Antimony, Copper, Chromium
Purity requirements
[mg/kg]
max. 20
not detectable
max. 200
max. 5
max. 100
Besides to a good manufacturing practice, attention should also be paid to a careful
selection of raw materials. Otherwise it can be assumed that the purity requirements for the
raw material are not complied.
Sources:
1
2
BGA (1985) Information from the Federal Health Office: "Technically preventable contents of
heavy metals in cosmetic products", Federal Health Gazette 28 (7), 216
BVL Monitoring Reports 2011-2013:
http://www.bvl.bund.de/DE/08_PresseInfothek/04_Publikationen/03_Berichte/infothek_berichte_node.html
3
BfR (2006): "Cosmetic products: BfR recommends to regulate heavy metal contents on the
purity requirements of raw materials", Opinion No. 025/2006
Contact Information:
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representative or email to: [email protected]
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Jan 2017, 17B-001