Product recall requirements

Recall criteria

What criteria apply for determining when a matter requires a product recall or other corrective actions?

Article 8 of RD 1801/2003, in relation to the Consumers General Act, states the general principle according to which the applied corrective measures must be congruent with the causes that originated them, as well as proportionally related to the risk that is faced. Once these requirements are covered, it is necessary to apply measures that are less restrictive of the free circulation of merchandise, liberty of enterprise and whatsoever affected right regarding these matters.

However, the administration is granted, in general, a high degree of discretion to take measures it may consider appropriate to the current case.

Among the corrective actions likely to be applied, besides recall, there is the possibility for sealing and preventing further movement of the product, recovery of the product from consumers, destruction of the product, and suspension of activities, selling and special offers.

Nevertheless, article 10 of RD 1801/2003 foresees special cases where specific measures should be taken:

  • if there are signs of defects, the product supply should temporarily be suspended until, according to the respective evaluation, there is certainty of the safety of the product;
  • if the risk of the product could be avoided by certain modifications and express warnings to consumers, before it is introduced in the market, the administrative request would specify what kind of warning should be added to the product and only then will it be able to circulate in the market; and
  • regarding the recall: the regulation only states that when a product does not comply with the definition of ‘safe product’ and it has been introduced in the market, will it be subject to recall, recovery or destruction.

For the purpose of the previous points, it is convenient to bear in mind that the definition of ‘safe product’ is, according to article 2 of RD 1801/2003, any product that in normal and rationally predictable conditions of use does not entail any risk to people’s health and safety.

Moreover, in Spain, a product will be deemed safe when it fulfils the requirements of health and safety as set out in specific regulations or, if it is not specifically regulated, it is at least supposed to be in accordance with technical national rules that harmonise European rules, UNE rules (the Spanish quality and standardisation rules), good practice codes and the current status of technical knowledge.

There is also a presumption of defective products, which basically comprises a lack of administrative authorisations for the product and a lack of information with which to identify the producer, and where the product belongs to a group of products where one of them was deemed defective. In such cases, the product may be deemed defective, irrespective of its actual state, according to article 3 of RD 1801/2003.

In the case of medicines, the specific regulations are more restrictive, since article 99 of Act No. 29/2006 states that upon the suspicion of the existence of an imminent and serious risk to health, the competent authorities may take the following measures:

  • quarantine, recall from the market and prohibition of use of the medicines and suspension of activities and advertising, as well as the closing of premises, which means the automatic blocking of the circulation of the products; and
  • suspension of the manufacture, prescription, sale and supply of the medicines.
Consumer warnings

What are the legal requirements to publish warnings or other information to product users or to suppliers regarding product defects and associated hazards, or to recall defective products from the market?

The general requirements that producers or distributors should comply with to implement a measure to warn consumers and protect consumers from the defective product will be specified in the request made by the administrative authority for those who do not fully comply with the safety of products.

Such enquiry will include the time or deadline producers or distributors have to carry out the warning and a recommendation for corrective actions, but also grants freedom to the producer or distributor to act as it deems appropriate (unless it is expressly regulated in a specific case), according to article 9 of RD 1801/2003.

Moreover, to adopt the measures previously listed, it is necessary to carry out the administrative procedure referred to in Act No. 39/2015. However, it will not be necessary to complete every single phase of the procedure, such as certain hearings and proof phases, as long as the hearing and evidence have been carried out before another administration of an autonomous community.

During the proceedings, the technical commission for product safety (or similar autonomous institutions) has been required to issue a report and those have already provided the corresponding hearings, and their ruling does not substantially differ from that report.

Furthermore, Royal Decree No. 85/2018, of 23 February, on cosmetic products determines a specific procedure of communication and transmission of unwanted serious risks and effects particular for cosmetics and establishes a Spanish system of cosmetic surveillance.

Recall notices

Are there requirements or guidelines for the content of recall notices?

As stated in question 13, according to article 9 of RD 1801/2003, the enquiry from the administration will specify:

  • the result intended from the request;
  • a deadline for fulfilling the request;
  • the monitoring of the procedure; and
  • the administration may recommend measures to take to obtain the result, but the entity subject to such enquiry may take other measures that lead to the intended result.

If the petitioning party does not take the necessary measures or the measures taken are insufficient, the administration may implement the measures listed in article 10 of RD 1801/2003 (see question 12).

Moreover, there is a guideline document for manufacturers and distributors or suppliers provided by various European health ministries that offers information about how to proceed when they have knowledge of an imminent risk presented by a certain product. These guidelines may be found on the following websites:

  • www.prosafe.org; and
  • www.aecosan.msssi.gob.es/AECOSAN/docs/documentos/consumo/seguridad_productos/guia.pdf.
Media

What media must be used to publish or otherwise communicate warnings or recalls to users or suppliers?

In general, according to what has been stated, the petitioning party may choose which media it prefers to use to communicate the warning or recall to users and suppliers. If the administration considers that the measures taken are not sufficient, it may implement measures according to article 10 of RD 1801/2003.

However, regarding medicines, regulations that state that the National Medicine Agency will publish, by means of the appropriate media, the methods undertaken to let all the potentially affected persons know about these measures.

Concerning food products, the president of the Spanish Consumer, Food Safety and Nutrition Agency will evaluate the risk before creating crisis and emergency committees, which will carry out the due procedures according to articles 34 and 35 of RD 19/2014.

Time frame

Do laws, regulation or guidelines specify targets or a period after which a recall is deemed to be satisfactory?

As mentioned above, regarding the measures to be taken, the competent authority will first be the administration from the autonomous communities that have responsibility - whose actions must always be reasonable and justified - to impose the measures for a reasonable period, always considering the right of free business and the interests at stake.

However, according to article 11.6 of RD 1801/2003, when the competent authority is the central administration, the measures taken must not exceed six months.

Act 29/2006, regarding defective or hazardous medicines, foresees that measures taken may be subject to further extensions if the nature of the risk justifies it.

Repair and replacement

Must a producer or other supplier repair or replace recalled products, or offer other compensation?

The recall of products is an administrative measure to prevent further damage to consumers. Moreover, all regulations that establish recall measures foresee that those measures may be taken without prejudice to eventual civil or criminal actions.

This means that if, according to the General Consumers Act and the Civil or Commercial Codes, the consumer or the purchaser of the affected goods can prove that he or she has suffered damage arising from the measure, such consumer or purchaser might be entitled to claim for the damage suffered.

These measures are also foreseen in article 12.5 of RD 1801/2003, in general, and article 100 of Act 29/2006 for medicines.

Penalties

What are the penalties for failure to undertake a recall or other corrective actions?

When the public authorities deem that the entities that caused the infraction are not duly cooperating, they can proceed to perform the necessary actions themselves or with other entities’ collaboration.

The fines that the administration may impose for a lack of collaboration with the measures taken (ie, the recall of the product or any other corrective measure) will be those stated in the General Consumers Act, Act 14/1986 or Act 29/2006, depending on the nature of the infringement, in the terms set out in question 3.

In general, this infringement will be considered as a minor infringement. However, depending on the nature of the risk and the interests at stake, the law allows the administration to deem the infringement serious or even major.