What is formaldehyde?

Formaldehyde is a naturally occurring colourless chemical composed of hydrogen, carbon and oxygen. Although it cannot be seen, it has a distinct odour, making it easily identifiable. Naturally-occurring formaldehyde is found in humans, animals, plants, fruit, vegetables, meats and beverages. In the human body, it is a critical molecule for the formation of RNA and DNA.
Formaldehyde is also a by-product of the oxidisation and combustion of certain products, and is released from forest fires, car exhausts and tobacco smoke. It is estimated that more than two thirds of all formaldehyde emissions in the atmosphere result from natural emissions from vegetation and forest fires. Formaldehyde is quickly broken down by sunlight and does not accumulate in the environment.

Why do we manufacture formaldehyde?

Formaldehyde provides exceptionally high chemical reactivity in the most resource efficient way. It is the smallest and simplest molecule delivering carbonyl functionality for the manufacturing of polymers and plastics. It does not waste material and energy during its production and use. Formaldehyde manufactured for industrial purposes is identical to the formaldehyde naturally occurring in the environment.

How is formaldehyde made?

Industrial formaldehyde is produced by the reaction of methanol with oxygen. Industrial manufacturing of formaldehyde is extremely energy efficient. Energy is released and captured during formaldehyde production. In addition, process gases from formaldehyde production are routinely burned to produce steam and electricity. Emissions to air and water are extremely low.

What is formaldehyde used for?

Formaldehyde is mainly used as an intermediate in the production of resins and polyols.  Industrial applications include wood panels, construction materials, automotive and aircraft components, healthcare and cosmetic products, and clothing.

These find application in a multitude of different household products, including furniture, flooring and cabinets. It is also used in the manufacture of car components, such as external coatings, brakes, tires, seat-belt systems, seats and door panels, as well as being an ingredient in textiles, to help bind dyes and make clothes wrinkle-resistant.

How big is the formaldehyde industry?

Over 3 million tonnes of formaldehyde are produced each year in Europe, creating over 30,000 direct jobs in the chemical processing sector.  Downstream industries which rely on formaldehyde, such as the wood-based panels and furniture industries, and the suppliers of the automotive industry, employ more than 1.7 million people across Europe.

Is formaldehyde safe to use?

Yes. An independent risk assessment, carried out by two leading independent consultants TNO Triskelion and RPA (Risk & Policy Analysts Ltd) was carried in 2013. They reviewed large amounts of published exposure data and concluded that formaldehyde levels in dwellings are well below the safe concentration established by the WHO.

The WHO set the safe concentration limits for indoor air at 0,1mg/m³. According the WHO, this value is protective for both short-term and long term effects. The value can also be used as a reference to assess to risk in the outdoor environment.

TNO Triskelion and RPA also assessed exposure levels at the workplace and concluded that industry operates safely in all current uses.  In some cases, safe use requires appropriate Risk Management Measures, such as operators wearing half-masks, and the application of suitable operating conditions, for example adequate ventilation systems. The risk assessment was based mainly on recently-measured worker exposure data from EU formaldehyde production and downstream user plants.

A Summary of the TNO and RPA conclusion can be found here.

How is formaldehyde classified in Europe?

In 2014, formaldehyde was reclassified as a carcinogen category 1B.  According to the EU Classification, Labelling and Packaging Regulation, category 1B substances are presumed to have carcinogenic potential for humans, based on animal evidence.  The rationale for this classification was not based on new evidence but was triggered by a change of the classification criteria and their interpretation under REACH.

The new classification entered into force on 24 June 2014. However authorities have foreseen a transition period allowing suppliers to adapt to the new classification until 1 January 2016.

What does the classification cover?

The classification is based only on nasopharyngeal cancer, one of the rarest forms of cancer in the EU.  Experts from the EU’s Committee for Risk Assessment rejected possible links to leukemia. Since the epidemiology evidence does not support a link for humans, the classification is based entirely on evidence from animal studies. For this reason the EU reclassified formaldehyde as carcinogen 1B (presumed human carcinogen) instead of 1A (known human carcinogen).

What does the classification mean?

In principle classification does not consider risk, as the classification system in the EU is strictly hazard-based.

The classification was established based on animal tests under high exposure conditions.  The classification does not take into account whether this presents a real risk to workers or consumers.

Formaldehyde differs from most carcinogens in that exposure thresholds can be defined below which safe use can be established.

What is the regulatory status of formaldehyde under REACH?

Formaldehyde was registered under REACH in 2010.

In 2012, formaldehyde was included on the second CoRAP List for REACH substance evaluation, to clarify if the substance is used safely and adequately regulated.  This process began in February 2013, performed jointly by co-rapporteurs France and the Netherlands. Timing depends largely on the information requested by the rapporteurs during the process. Once the evaluation is complete, France and the Netherlands may conclude that the risks are sufficiently under control, and that all necessary control measures are already in place. Otherwise, they can propose EU-wide risk management measures such REACH restriction or authorisation.

Specifically on worker exposure, France officially announced a Risk Management Option Analysis in September 2015 and should recommend the best options in the course of 2016.

Formaldehyde has not been identified as a SVHC and is not being considered for authorization.

What is the current status on a possible harmonized occupational exposure limit?

Separate legislation governs occupational health and safety, managed by the EU’s Directorate General for Employment (DG EMPL), and its dedicated scientific committee, the ‘SCOEL’.

Currently, there is no EU harmonized Occupational Exposure Limit (OEL) value for formaldehyde. National OEL’s are in place, generally in the region 0.3 – 0.5 ppm.

Recently, the SCOEL reviewed an extensive body of literature to define an OEL at European level and proposed an OEL recommendation at 0.3 ppm (TWA) and 0.6 ppm (STEL).