Understanding the principles of REACH
The European Regulation EC 1907/2006 – is a European Union Regulation that covers the Registration, Evaluation, Authorization and Restriction of Chemicals. Normally referred to as “REACH”, it came into force on 1 June 2007. The regulation also established the European Chemicals Agency (ECHA), which manages the technical, scientific, and administrative aspects of REACH. Although a European Regulation, from time to time, we get questions about how this may affect certification or registration of products with NSF.
NSF Expert Delfina Buening provides an overview for those who may not be familiar with the regulation.
Why was REACH introduced?
One of the main aims of REACH is to help industry to assess hazards and risks of the substances, and to identify and implement the risk management measures to protect humans and the environment.
This is done by the four processes of REACH: the registration, evaluation, authorization, and restriction of chemicals. REACH also aims to enhance innovation and competitiveness of the EU chemicals industry.
What and Whom Does REACH Apply To?
REACH applies to all chemicals imported or produced in the EU. There is a list of chemicals that are excluded from the REACH regulation such as radioactive substances and substances used in foodstuffs.
The regulation applies to all organizations who manufacture or import chemical substances into the European Union in quantities of one metric tonne or more per year. Organizations are required to register these substances with the European Chemicals Agency (ECHA).
How Does REACH Work?
Registration means providing a technical dossier on the chemical, it’s physicochemical and toxicological properties and the hazards when handling.
The information required for each substance depends on the tonnage manufactured or imported. This includes a technical dossier and, for substances manufactured or imported in quantities of 10 metric tonnes per year or above, a Chemical Safety Report (CSR). This is submitted via the REACH-IT portal.
The registration phase is not the end game of REACH. The law stipulates that companies should regularly update their registration dossiers to ensure that the data on safety of chemicals is complete and up-to-date.
EvaluationECHA and the Member States evaluate the information submitted by companies to examine the quality of the registration dossiers, the testing proposals and to clarify if a given substance constitutes a risk. Once the evaluation is done, registrants may be required to submit further information on the substance.
The authorization process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.
Substances of very high concern (SVHC) are:
- C - Carcinogens category 1A or 1B
- M - Mutagens category 1A or 1B
- R - Toxic to reproduction category 1A or 1B
- PBT - Persistent, bio accumulative and toxic
- vPvB - very persistent and very bioaccumulative
- ELoC - Substances with an equivalent level of concern to those listed above (e.g., endocrine disruptors, respiratory sensitizers)
RestrictionsREACH includes a restriction process for certain substances of very high concern if they pose an unacceptable risk to health or the environment. Such substances may be limited or even banned, if necessary. The restriction is designed to manage risks that are not addressed by the other REACH processes or by other EU legislation.
REACH and Brexit
Since the United Kingdom left the European Union, UK and European REACH regulations operate independently. This means that if you are placing chemicals on the market in the UK, you will need to meet the UK requirements. However, EU REACH continues to apply in Northern Ireland.
REACH and NSF
NSF uses the US FDA food contact regulations in the evaluation of substances for food contact application under NSF/ANSI 51 certification and also under the Nonfood Compounds registration programs.
That said, NSF has used information from REACH registered chemicals such as the boiling point information to clear an ingredient that is used for food contact application.
For example, if the boiling point of the ingredient is below the cure temperature, then that ingredient is deemed to volatilize and therefore is considered no longer present in the food contact material.
Substance information cards for each registered chemical can be accessed via the ECHA website.
Whilst other sources are also checked, when a chemical is profiled under the Safer Chemistry program at NSF, the ECHA is the go-to source for the most up to date toxicology studies. This enables us to determine if the chemical meets the Safer Choice criteria.