There are extensive and detailed regulations at an international and European level on the packaging and the transportation of samples. However, lack of knowledge of these regulations frequently results in mistakes which endanger the safety of the persons exposed to these substances, and even fines and penalties.

The WHO publish guidance on the regulations; according to their indications, the United Nations Economic Commission for Europe (UNECE), was in charge of drawing up the European Agreement on the international transport of dangerous goods by road (ADR).

This is all specified in Packaging Instruction P620 (for Category A) and P650 (Category B). Furthermore, packaging that complies with what is stated in these instructions also aids compliance with the transport regulations regarding Prevention of Occupational Risk.

Spanish legislation

Regarding transport

The ADR regulates packaging, documentation and other aspects of the transportation of dangerous goods by road, including loading, unloading and storage of the same, whether it be international or not. One important aspect is the establishment of the obligations and responsibilities of each of those involved in the operations, in order to avoid possible damage as well as protect the environment (Chapter 1.4).

Along with the ADR, the Spanish legislation is strongly influenced by the European legislation, and can basically be summarised into four rules:

  • Law 16/1987 of 30 July, for the regulation of land transport. The Law (or LOTT), affects the transportation by road or railway of goods or passengers. In article 66.2 (Classification into ordinary and special transport) it indicates that the transport of dangerous goods will be considered to be special, and subject to specific ADR regulations.
  • Royal Decree 1211/1990 of 28 September, in which the Rules of the Law for the Regulation of Land Transport were passed.
  • Royal Decree 551/2006 of 5 May, which regulates the transport of dangerous goods by road within Spain. The first article makes it clear that the ADR is not only to be applied to international transport, but also to that carried out wholly in Spain.
  • Royal Decree 1566/1999 of 8 October, on security advisors for the transport of hazardous goods by road, rail or water. It makes it compulsory to have a safety advisor in the company.
Regarding prevention of occupational risk

Law 31/1995 of 8 November, for the Prevention of Occupational Risk, has been implemented by various Royal Decrees. Two of these, modified in order to align with different European directives and relevant to our field are:

  • Royal Decree 1215/1997 of 18 July, in which the minimum requirements for safety and health in the use of work equipment by the workers are established.
  • Royal Decree 664/1997 of 12 May, on the protection of workers against the risks related with exposure to biological agents during work. In article 6, paragraph C, it demands the "adoption of safety measures in the reception, handling and transportation of biological agents within the workplace."

International guidelines


Guidelines of the World Health Organisation (WHO) regarding the management of biological risk and infectious substances.


European Agreement on the international transport of dangerous goods by road. Updated every two years, it contains the basic regulations on the minimum conditions in which a hazardous substance can be transported.


The International Air Transport Association (IATA) is the instrument for the co-operation between airlines. it promotes safety, reliability, confidence and economy in air transport, for the economic benefit of its private shareholders.

Website IATA

Packaging Instruction PI650

Keys for a correct approach to management

Safe packaging and transport of clinical samples

Before proceeding to package and transport a substance, it is essential to know whether it must be assigned to a certain category and treated in a specific way.

The transportation of substances, according to their classification

The WHO classifies infectious materials in three categories which will determine how they should be treated, and the logistics with respect to transportation.

What should a container be like? Triple packaging

The containers designed for the transportation of infectious substances must always comply with the Triple Packaging System recommended by the WHO.

What tests must a container pass?

Each container must pass strict resistance tests certified by the appropriate competent authority.

Packaging of Category A samples

Category A infectious materials can only be transported in packaging/containers which have passed strict resistance tests.


The different regulations were designed to protect the environment and the persons involved in the handling, packaging and transportation of hazardous biological substances.