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General product obligations
What are the basic laws governing the safety requirements that products must meet?
The basic laws governing the safety requirements that products must meet are:
- Law 9/1979 (Sanitary Measures Statute - SMS), which contains the general rules and principles mainly governing products that might entail significant health risks, such as food, medical and cosmetic products; and
- Law 1480/2011 (Consumer Protection Statute - CPS), which contains the general rules and principles governing consumer’s safety. According to the CPS, an ‘unsafe or defective product’ is one which does not offer the reasonable safety standard that any person is entitled to, due to the product’s design, manufacturing, construction, packaging or information. A product that does not meet the safety requirements stablished in technical and sanitary regulations is legally presumed unsafe.
Specific rules and requirements are usually adopted through technical and sanitary regulations issued by different government agencies - mainly ministries and sometimes superintendencies - depending on the nature of the product. Most of those requirements are compiled and monitored by the two main supervisory agencies on product safety: the National Institute for Medicine and Food Surveillance (INVIMA) and the Superintency of Industry and Commerce (SIC).
What requirements exist for the traceability of products to facilitate recalls?
There are no prior requirements for the traceability of general products, although the notification to the SIC of defects discovered in products must include the product reference and lot number, date of import or production and, if possible, dates and places in which the product was available for sale and number of defective units. Therefore, keeping track of this data might facilitate a potential notification and recall plan.
What penalties may be imposed for non-compliance with these laws?
Non-compliance with product safety laws may result in criminal, civil and administrative penalties.
Criminal penalties may be imposed for the sale or distribution of defective alimentary, medical or prophylactic products (article 372 Criminal Code). Criminal penalties range from fines (up to 1,500 monthly minimum wage - as of 2018, 1.171 billion pesos) to prison (up to 12 years). In any case, if the defective product damages someone’s property or causes bodily injury or death, the person responsible for these criminal offences may be prosecuted according to the Criminal Code.
As for civil sanctions, the manufacturer and retailer are jointly and severally liable for bodily injury, death and material damages caused by defective products and for the failure to comply with the duty to notify the SIC of defects discovered in products manufactured or sold by them.
Government agencies, such as the SIC and the INVIMA, may also impose administrative penalties for the non-compliance with these laws and regulations, such as fines, temporary or permanent closure of commercial establishments, prohibitions to manufacture or sell certain products, order to destroy defective products, product confiscation, among others.
Reporting requirements for defective products
What requirements are there to notify government authorities (or other bodies) of defects discovered in products, or known incidents of personal injury or property damage?
Any member of the chain of production, distribution or retail who finds out that any kind of product manufactured, distributed or sold by them has a defect that may cause or has caused damages, must notify SIC as further described below (article 19, CPS and Decree 679/2016). In the case of medical products, INVIMA must also be notified (article 26, INVIMA Resolution 1403/2007). Notification to other government agencies might be required, depending on the product concerned.
Notification criteria and time limits
What criteria apply for determining when a matter requires notification and what are the time limits for notification?
Notification is required whenever the defect may cause or has caused an incident with adversely affects the health, life or safety of people. Notification must be filed within the three calendar days after learning of the defect, which is deemed to have happened once the producer, distributor or retailer:
- has been informed by a consumer or any other member of the chain of production, distribution about the unreasonable risks that the product poses;
- learns that the product might not comply with any safety requirements established in technical and sanitary regulations;
- learns that the product does not offer the reasonable safety standard that any person is entitled to, due to the product’s design, manufacturing, construction, packaging or information;
- learns that the product might pose a safety risk according to scientific or technical knowledge, or that the product does not comply with safety requirements established in international technical standards;
- learns of the existence of an investigation regarding the product defectiveness; or
- notifies other countries’ authorities of the defects.
To which authority should notification be sent? Does this vary according to the product in question?
Regardless of the type of product, the SIC should always be notified (article 19, CPS and Decree 679/2016). In the case of medical products, the INVIMA must also be notified (article 26, INVIMA Resolution 1403/2007). Notification to other government agencies might be required, depending on the product concerned
What product information and other data should be provided in the notification to the competent authority?
The notification to the SIC should include:
- identification of the product by:
- name under which the product has been marketed and sold;
- type of product;
- reference and lot number;
- import and production date;
- dates during which the product has been sold;
- number of defective units; and
- places where the product has been sold.
- picture of the product;
- a description of the action plan;
- a description of the defect and its risks;
- the number and description of reported damages or victims;
- the most relevant distributors and retailers of the product, along with contact information for their representatives;
- a description of the corrective actions that have been and will be taken; and
- the procedure designed to return the product and refund its price, as well as its expected results.
It should be noted that the SIC might request further information.
Obligations to provide updates
What obligations are there to provide authorities with updated information about risks, or respond to their enquiries?
There are no specific obligations to provide the SIC periodic updates after initial notification, although it is advisable to do so. SIC may request updates and ask for clarifications, which must be attended within their set deadlines, unless there are reasonable grounds to ask for extensions.
What are the penalties for failure to comply with reporting obligations?
Although no criminal offences specifically referred to a failure to report, if the non-reported product causes damage to property, personal injuries or death, the person responsible for these criminal offences may be prosecuted according to the Criminal Code.
The CPS provides for a joint and several liability between those that fail to comply with reporting obligations and the manufacturer, for injuries and other damages caused by defective products.
The SIC may also impose administrative penalties for the non-compliance with these laws, such as fines, temporary or permanent closure of commercial establishments, prohibitions to manufacture or sell certain products, order to destroy defective products, product confiscation, among others.
Is commercially sensitive information that has been notified to the authorities protected from public disclosure?
In general terms, any person can access administrative records and files, although sensitive information is protected from public access. It is advised to specify and mark commercially sensitive information and specifically request that measures be taken to prevent public disclosure.
Use of information in prosecution
May information notified to the authorities be used in a criminal prosecution?
There are no laws forbidding the use of the information notified to the authorities in criminal prosecution. Besides, any public authority that learns of a possible occurrence of a criminal offence must immediately report it to the competent authorities.
Product recall requirements
What criteria apply for determining when a matter requires a product recall or other corrective actions?
There are no set criteria for determining whether a product recall is required or other corrective actions are sufficient. Any member of the chain of production, distribution or retail that finds out that any kind of product manufactured, distributed or sold by him or her has a defect that may cause or has caused adverse effects on health, life or safety of people must take ‘appropriate measures’ to prevent damages. Appropriateness might depend on the type of product and defect (eg, a lack of safety warnings or instructions may be corrected by publicising said warning or instructions, with no need for recall).
Additionally, the producer and importer should:
- suspend production and dispatch of the product until corrective measures are adopted;
- notify the distributors and retailers about the defect, request them to stop selling the product until corrective measures are adopted and direct them to isolate and mark the defective products within their control; and
- notify consumers about the defect by appropriate means.
Distributors and retailers must also:
- suspend distribution and sale of the product;
- request the producer and importer the information to be provided to the consumers; and
- notify the consumers about the defect and the action plan by appropriate means.
The producer must either destroy or repair the defects of the isolated and recalled products.
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?
Distributors and retailers must try to establish direct contact with the users and inform them about the defect and the action plan. If such contact is not possible, a press release must be published in a media outlet with an intensity and frequency that is consistent with the sales volume, the number of consumers and the way in which the product was marketed.
In July 2017, the SIC launched a web portal to publish product warnings and action plans (http://seguridadproducto.sic.gov.co/). In the web portal, consumers can check reports of defective products, as well as the details of the recall or action plan implemented by manufacturers and sellers. Although there is no legal requirement for producers, importers, distributors and retailers to directly post their reports on the web portal, the SIC will usually require them to create an account and post any relevant information once a notification notice has been filed with the SIC.
As for the recall requirements, the producer or importer must design the procedure to recall and isolate the defective products, as well as bear the associated costs.
Are there requirements or guidelines for the content of recall notices?
Recall notices to the SIC, as well as any other preventive or corrective plan, must contain the information mentioned in question 7.
As for public recall notices, there are no specific requirements. The required information that should be uploaded to the web portal mentioned in question 13 contains:
- identification of the product;
- name under which the product was sold;
- type of product;
- identification of the producer, importer or brand used; and
- description of the defect and its associated risks.
What media must be used to publish or otherwise communicate warnings or recalls to users or suppliers?
A ‘suitable’ media outlet must be used. Suitability is assessed considering the sales volume, the number of consumers and the way in which the product was marketed.
Do laws, regulation or guidelines specify targets or a period after which a recall is deemed to be satisfactory?
There are no targets or periods after which a recall is deemed to be satisfactory. However, the SIC may determine a desired result, set a deadline to achieve it and make recommendations to do so.
Repair and replacement
Must a producer or other supplier repair or replace recalled products, or offer other compensation?
The producer must either destroy or repair the defects of the isolated and recalled products. If the product is destroyed, the consumer may choose between a product replacement and a price refund.
What are the penalties for failure to undertake a recall or other corrective actions?
The penalties for failure to undertake a recall or other corrective actions are described in questions 3 and 9.
What powers do the authorities have to compel manufacturers or others in the supply chain to undertake a recall or to take other corrective actions?
The SIC has wide powers in product safety matters. Under the CPS, it may order any measure that is necessary to avoid consumer damages. The most usual compelling powers include successive fines, temporary closure of commercial establishments, as well as prohibitions to manufacture and distribute the product. Although the producer, importer, distributor or retailer has a certain flexibility to design the proposed action plan, the SIC might request further actions or specify how certain actions should be taken.
Can the government authorities publish warnings or other information to users or suppliers?
Both the SIC and the INVIMA can publish warnings to users and suppliers. In July 2017, SIC launched a web portal for the disclosure of product warnings and action plans (http://seguridadproducto.sic.gov.co/). The SIC must publish information about any reports on defective products and will usually direct producers, importers, distributors and retailers to do the same. Members of the public cannot directly post remarks or reports of incidents, but they can check reports of defective products, as well as the details of the recall or action plan implemented by manufacturers and sellers and request the SIC to take action.
Can the government authorities organise a product recall where a producer or other responsible party has not already done so?
The SIC will initially compel producers, importers, distributors and retailers using the powers mentioned in question 19. Although under Colombian law there is no specific power to do so, if those powers are ineffective, the SIC can organise a product recall and implement other corrective actions under its wide powers and duties in product safety matters.
Are any costs incurred by the government authorities in relation to product safety issues or product recalls recoverable from the producer or other responsible party?
Under Colombian law, recall and other corrective actions expenses must be borne by the members of the production and distribution chain. Therefore, any reasonable costs incurred by the government authorities may be recovered from the party that fails to comply with product safety obligations.
How may decisions of the authorities be challenged?
The affected party may request the authority to reconsider its decision and file a judicial claim to annul it and compensate any damages arisen from the annulled decision. The judicial review complaint should be filed within four months of the date on which the decision was officially notified (or from the date that a motion to reconsider the decision was declined) and the claimant has the burden to argue and prove that the decision, its basis or its procedure violate constitutional or legal rules or principles.
Implications for product liability claims
Implications for product liability claims
Is the publication of a safety warning or a product recall likely to be viewed by the civil courts as an admission of liability for defective products?
There are no specific evidentiary rules that consider or prohibit the publication of a safety warning or a product recall as an admission of liability for defective products. Publication of safety warnings and product recalls should be weighed and assessed by the courts along with all the relevant evidence to determine whether liability for defective products arises. It might be viewed as a piece of evidence of the existence of the defect, but the claimant would still be required to prove damages and causation.
Can communications, internal reports, investigations into defects or planned corrective actions be disclosed through court discovery processes to claimants in product liability actions?
Those kind of documents may be disclosed through court discovery processes in product liability actions, excluding the ones under professional secrecy, such as the lawyer-client privileged communications.
Updates and trends
Updates and trends
Updates and trends
The SIC has played an active role in reporting obligations and the implementation of recall or other action plans. Under its wide supervisory powers, the SIC will usually request information from manufacturers, distributors and retailers and check for its consistency, carry out unannounced inspections and follow up on the action plans. The SIC will usually require manufacturers, distributors and retailers to directly post their reports of defective product and action plans on the web portal launched in July 2017 (http://seguridadproducto.sic.gov.co).