Monday, April 27, 2015

Next REACH Deadline Cometh

The key upcoming deadline concerns substances manufactured or imported into the EU in relatively low volumes, only 1 to 100 tonnes per year.The European Chemicals Agency (ECHA) encourages businesses to start preparing now. Below please find a checklist that may help with preparation programs.

Low volumes represent a big compliance challenge because many small to mid-sized businesses either ship chemicals in that range or use chemicals in that range in their products.

To find out exactly what substances you might be responsible for in your products, mixtures and articles, most companies are now using product ingredient tracking software. Tracking software culls a Bill of Materials and queries suppliers for substance-level data. Over time, the data is collected in an organized fashion in a rational database. This means reports can be run and meaningful information and compliance docs can be extracted easily and quickly from the data. Actio Corporation has put together a checklist for what to look for in REACH compliance software. Included is WEEE and RoHS regulations -- because the process for supplier data collection is similar can can be cross-purposed for all. Complimentary download, but you are asked to enter your name and email.

You likely have upcoming registration obligations under REACH if your business:
  1.     Manufactures chemicals or imports them from outside the EU above one (1) tonne per year
  2.     Manufactures or imports any product (mixture, article), as it may contain substances that need to be registered individually
ECHA published a notice recently reminding companies to start preparing for the upcoming deadline now. More info is available on the ECHA website.

Tuesday, April 21, 2015

K-REACH Definitions Clarification

Many questions around Korea's chemical regulation are related to the definition of "product" under Korean chemical law, the so-called K-REACH. Korea's chemical law is similar to REACH chemical regulation in Europe. Hence the K-REACH moniker.

What is Product under K-REACH? It turns out that if you're wondering about definitions of "Product" under K-REACH, you're not alone. Here is additional guidance on the matter. Special thanks to A. Burr at American Chemistry Council via the ANSI network for sharing thoughts.

K-REACH Definition

Substances in product definitions:
  1. "Product" is defined in Article 2 of Korea's law as mixture or solid objects that are "likely to result in the exposure of chemicals to consumers as final consumer goods or parts thereof and accessories"
  2. According to one guidance document, "products" are only "consumer products" (i.e., used by consumers, including at work service facilities)
  3. Manufacturers and importers of products that contain a designated hazardous chemical substance >0.1% are required to report to MOE if the annual volume of the hazardous chemical exceeds 1 ton annually
  4. There are some exemptions (that must be confirmed), e.g., for solid form products with NO release of hazardous chemical substance during specific use.
  5. There are certain categories of products (e.g., household products and biocides) that must undergo risk assessment by MOE/NIER

K-REACH Big Picture

Broadly put, under Korea Toxic Chemicals Control Act (TCCA), an existing chemical is a chemical that was domestically commercialized prior to February 2, 1991 and was designated and published by the Korean Minister of Environment in consultation with the Minister of Labor.

Pursuant to the TCCA, manufacturers or importers of new chemical substances are required to make notification to relevant authorities prior to the commencement of their commercial activities if the volume of the new substance exceeds 0.1 ton per year. KE numbers (serial numbers) and NIER (National Institute of Environmental Research) numbers are necessary for custom clearance.


Find out what was new in 2014 K-REACH.
Find out about K-REACH exemptions.

Tuesday, March 31, 2015

Registrants, Prepare to Comment

Registrants: prepare to comment on substance evaluation draft decisions. Soon, the European Chemicals Agency (ECHA) will send requests for further information about substances evaluated under the Community rolling action plan in 2014 to registrants for comments.

In 2014, Member States were evaluating 51 registered substances under the substance evaluation process. If further information is needed to assess the safety of the substance, they have prepared a draft decision. (The deadline for submitting a draft decision to ECHA was March 26, 2015. If you're late, contact ECHA immediately, they are often willing to work with you.)

ECHA has now received draft decisions on 40 substances. Registrants are preparing to give consolidated comments on the draft decisions addressed to them.

How to proceed

ECHA plans to send out the draft decisions to the relevant registrants May 4th through 8th. Registrants of these substances will have 30 days to consider and submit comments. A notification letter will specify comment deadline. If during those dates you feel you should have received a letter and did not, immediately contact ECHA with your query.

Registrants are encouraged to coordinate and speak with one voice; recommendation is that one representative, the Registrants Contact Point, should send consolidated comments on the draft decisions on behalf of all registrants.

So in the meantime, wait for your May letter. But have your comments ready.

Friday, February 27, 2015

Update: Information Requirements For Reproductive Toxicity

REACH Update: There are new information requirements for reproductive toxicity.

As of mid-March 2015 the REACH annexes VIII, IX and X have been amended with the inclusion of the Extended One-Generation Reproductive Toxicity Study (EOGRTS, EU B.56, OECD TG 443).

EOGRTS will now be the information requirement for reproductive toxicity in REACH instead of the old way, the two-generation reproductive toxicity study (EU B.35, OECD TG 416).

The updated annexes will enter into force March 13, 2015. ECHA is updating its guidance on reproductive toxicity to reflect the regulatory changes and aims to finalize it by July 2015. A draft is already available on ECHA's website.

Draft guidance:

Find out more here.

Thursday, February 5, 2015

How Are Substances Evaluated Under REACH?

Many ask, how does substance evaluation work under REACH regulation?

How it works is this:  Member States evaluate certain substances to clarify whether their use poses a risk to human health or the environment. The evaluation may conclude that risks are sufficiently under control via measures already in place. If current controls are not sufficient, the evaluation may lead to the proposal of EU-wide risk management measures such as:
  1. restrictions
  2. identification of substances of very high concern (SVHC)
  3. harmonized classification 
  4. other actions outside the scope of REACH

How are substances selected for evaluation?

In cooperation with the Member States, ECHA defines risk-based criteria and then selects the substances that are to be evaluated.

The selected substances are listed by ECHA in the community rolling action plan (CoRAP) following the opinion of the Member State Committee. More on CoRAP and its list of substances here.

An evaluating Member State will be designated for each substance on the final CoRAP.

And yes, we all wish they would change that acronym. It's not right.

The initial reason for selecting a substance for the CoRAP is not limiting the scope of the evaluation. During the evaluation, the Member State may identify other concerns that need clarification in order to conclude whether a substance is of concern or not. However, the Member State may focus the evaluation more upon certain aspects of the substance.

The substance evaluation process assesses all registration dossiers from all registrants specific to the same substance, i.e. in order to take into account the combined exposure. Other available sources of information are also considered.

The evaluating Member State has 12 months from the publication of the CoRAP to decide whether it needs to request further information from the registrants to clarify the concern.

And beyond

This request might go beyond the standard information requirements of REACH (Annexes VII to X) and may pertain to the intrinsic properties of the substance or its exposure. For example, registrants may need to provide studies on mode of action or monitoring of concentration levels in organisms or the environment, and the view that further information is needed is shared with all the other Member States and ECHA to achieve a general agreement. ECHA decides to request further information if necessary.

The objective is to request further information from the registrants of the substance to verify the suspected concern, if necessary.

For more specifics, see the ECHA substance evaluation fact sheet.

Friday, January 30, 2015


The national CLP help desks, ECHA and the Commission have agreed on five new CLP FAQs which have recently been published on ECHA's website.

These FAQs touch upon the following subjects:
  1. harmonized classification and labeling requirements
  2. mixture classification
  3. CLP pictogram requirements
  4. the classification, labeling and packaging requirements for biocidal products
The new FAQs use the unique IDs 1049, 1050, 1051, 1052, and 1053.

Find the new FAQs here.

Tuesday, January 6, 2015

New Version of PIC Regulation Reporting Tool

More material disclosure to manage in substance management: the PIC Regulation. During Q1 each year, European companies must report the specific quantities of chemicals subject to the PIC Regulation that have been exported/imported during the previous calendar year.

During the Q1 reporting season, companies must provide not just quantity information but also details on any and all non-EU based companies with which they traded PIC-regulated chemicals.

The deadline to submit the above information is 31st of March. ECHA would like exporters and importers to report sooner rather than later.

Technology update: ePIC 1.1

With the release of ePIC 1.1 on 8 January 2015, industry users will be able to generate and submit reports to their relevant Designated National Authorities. In the new version of ePIC, for most users a draft version of the reports is automatically generated and pre-filled by ePIC ("to the extent possible," says ECHA) with data available in the system.

Once the reports have been finalized, they can be sent to the Designated National Authorities for aggregation on country level.

The ePIC system will be down from January 7th at 09:00 (EET) until January 8th at 09:00 (EET).

PIC Guidance can be found here. Tools for managing compliance exist via third party vendors.

For more on the PIC regulation, please see ECHA's page.