2019.03.13

”It is not enough to have the world's best chemical legislation only on paper”

2019.03.13

ECHA promises improved control of new chemicals

Following last year's criticism, the European Chemicals Agency, ECHA, will improve the agency’s control of information on new chemicals submitted by the industry.

Text: Henrik Hamrén

ECHA seems to have responded to last year's criticism that the industry has so far gotten off lightly when it comes to meeting the requirements of the European chemicals legislation, REACH.

In a guest column in Chemical Watch, ECHA's executive director Björn Hansen promises, among other things, that the compliance checks of the industry's registration dossiers for chemicals will be considerably improved:

“It has become clear that the 5% compliance check of registration dossiers in each tonnage band has not had the desired effect”, Hansen writes. In 2019, ECHA will therefore need to focus more heavily on compliance checks, and make it “an agency-wide priority”.

Maintains confidence in the entire system

– It is very good if this gets better. The control function is central not only to be able to identify hazardous substances, and particularly substances of very high concern, but also to maintain confidence in the entire system, says Christina Rudén, professor of regulatory ecotoxicology and toxicology at ACES at Stockholm University.

The registration dossiers on new chemicals, submitted to ECHA by the industry, have to be compliant with the legal requirements in REACH. That means, among other things, that the dossiers have to contain enough information to enable assessments of potential risks related to the protection of human health. Since REACH came into force in 2007, Echa has received a total of about 65,000 dossiers for around 16,000 registered substances.

More problematic substances on the market

In its latest REACH Review, the European Commission found that the information in the registration dossiers is often poor. More than half of the evaluated turned out to be incomplete according to the Commission's own investigations.

The incomplete reporting by the industry has consequences for all other steps in the chemicals safety work involving REACH, says Marlene Ågerstrand, assistant lecturer at ACES at Stockholm University.

– The quality of the registration dossier is very important because it is the first step, in which it is determined how to proceed with a specific chemical and decide on, for example, restrictions or approval. Without good dossiers, you run the risk of getting more problematic substances on the market that have not been sufficiently investigated, she says.

Every third dossier lacks information

In October last year, the German Federal Institute for Risk Assessment (BfR) published a report, which showed that every third registration dossier in the lacks the toxicological information required according to REACH. The report concerned substances in the highest tonnage bands, produced in quantities of over 1,000 tonnes.

– It is not enough to have the world's best chemical legislation only on paper. This shows how important it is that you also ensure that the implementation of the laws works, says Marlene Ågerstrand.

Compliance checks are both time consuming and costly. With the current system, ECHA will never be able to fully evaluate all dossiers from the industry. According to Marlene Ågerstrand, however, they could be considerably more efficient by changing the work routines on a number of points.

– One thing would be to improve the first check that is made automatically, and become better at selecting which things are most important to look at in that first stage, she says.

Make better use of "no data, no market"

Another possible measure would be to make the control process more transparent, and enable, for example, external researchers to access and review the companies' dossiers and also contribute the information that may be missing.

Marlene Ågerstrand also thinks that Echa should be better at using Article 5 of the REACH legislation, No data, no market, saying that substances must be “registered in accordance with existing regulations" before they are allowed on the European market. In practice, Article 5 enables ECHA to withdraw permission to use a certain substance if the registrant does not submit the required data.

– This is definitely something ECHA can use to motivate the industry to submit better dossiers, she says.

Marlene Åkerkrans, ACES

Marlene Ågerstrand

Environmental chemist, ACES, Stockholm University
marlene.agerstrand@aces.su.se

Christina Rudén

Professor in ecotoxicology, ACES, Stockholm University
christina.ruden@aces.su.se