In a recent decision, the Supreme Court, ruling on a case concerning the alleged liability of the manufacturer of a tanning lotion, has interpreted the specific regulation on cosmetic products in light of the general provisions on product liability. In particular, the Supreme Court ruled out the liability of the manufacturer as the product had been used under abnormal and unforeseeable conditions.


In Italy cosmetic products are governed by Law no. 713/1986102 (and subsequent amendments). In particular, section 7 of Law No. 713/1986 provides that cosmetic products must not be harmful under normal or foreseeable conditions of use.103

The provisions set forth by Law no. 713/1986 on defectiveness of the product are similar to those provided for under Presidential Decree No. 224/1988 concerning liability for defective products104, currently encompassed into the Consumer Code.105 Particularly, section 5 of Presidential Decree no. 224/1988, now transposed on section 117 of the Consumer Code, sets forth the circumstances under which a product can be considered defective (i.e. the way in which the product was marketed and presented; the product information and warnings; the expected use; the time when the product was put into circulation). 106

The Supreme Court has interpreted the above provisions, covering a number of interesting issues relating to the liability of the manufacturer of cosmetic products.


The case was brought against the manufacturer of a tanning lotion107 by a woman claiming compensation for damages suffered following second and third degree burns with permanent after-effects, allegedly due to the use of the cosmetic.

On 30 June 2000 the first instance court upheld the claim for damages stating that claimant had successfully proved the causal link between the use of the product and the alleged damages suffered.

The first instance decision was overturned by the Court of Appeal of Catania based on the following grounds.

  1. The evidence submitted in Court confirmed the use of the product by the claimant and her exposure to the sun during the morning hours, but did not prove causation between the use of the tanning lotion and the alleged sunburns.
  2. The fact that the tanning lotion allegedly used by the claimant was not submitted in Court did not allow for chemical tests to be carried out to assess whether the product could have been altered as a consequence of incorrect packaging or due to other defects.
  3. As regards dosage and the time of exposure to the sun, the claimant did not regard the cautionary warning, which was required on the basis of the product information provided by the manufacturer.

The decision of the Court of Appeal was challenged by the claimant before the Supreme Court on grounds that: (i) section 7 of Law no. 713/1986 was incorrectly applied (ii) the Court of Appeal failed to examine the evidence submitted in Court (iii) the producer had the burden of proving that the cosmetic was compliant with regulatory and statutory requirements relating to the manufacturing and marketing of the product.


The Supreme Court reviewed the second instance decision and referred the case to a different panel of Judges of the Court of Appeal for them to reconsider the evidence submitted by the consumer in previous stages of the proceedings in light of the following principles stated by the Supreme Court.

Section 7 of Law No. 723/1986, as interpreted according to the general provisions on product liability108, does not establish an absolute strict liability of the manufacturer of cosmetic products. Indeed, according to section 7 of Law No. 723/1986, the cosmetic product shall be considered defective - with consequent possible liability of the manufacturer - when such product is considered as harmful for human health under the normal conditions of use. To the contrary, the manufacturer's liability shall be excluded in case of 'abnormal use' of the product, which occurs not only when the product is used under abnormal and unlawful conditions, but also in the event of occurrence of highly anomalous circumstances - albeit not directly ascribable to the consumer - leading the harmless product to become capable of causing health injuries. Said circumstances include the consumer's health conditions - even when temporary - during the use of the product.

Finally, the Supreme Court found that, even when the product is used under normal conditions, the damage per se does not prove the dangerous nature of the product, which is not sufficient per se to establish the manufacturer's liability, unless it is ascertained that the product does not comply with the standards of safety prescribed by law or that users can legitimately expect.


The interpretation given by the Supreme Court appears to be in line with the recent case law, according to which the health damage occurred to consumers as a consequence of the use of a cosmetic product is not sufficient to prove the dangerousness of the product and hence the manufacturer's liability.109

In assessing the manufacturer's liability the Judge shall consider the way in which the product was used; no liability can be ascribed to the manufacturer in case of abnormal use of the product by the consumer.

In light of the above mentioned approach followed by Supreme Court, the manufacturer can only be held liable when the consumer proves i) that the product was used under normal conditions; ii) the product did not comply with the standards of reliability legitimately expected by users or prescribed by law iii) causation between the use of the product and the damage allegedly suffered is substantiated.