Helping you assess chemicals for new CLP hazard classes
Hardened experts for classification of Endocrine disruptors, PMTs and PBTs
Adam Jonas
Regulatory King
Ecotoxicology expert
What does it take and how much does it cost?
Rapid
screening
Tier 1
1 substance: €2.500
2-5 substances: €1.900 per substance
6+ substances: get a tailored quote
What does it take?
- Checking current lists of known endocrine disruptors and substances already assessed for ED properties in the EU as well as non-EU countries
- In silico modelling of ED, PMT and PBT properties ((Q)SAR modelling and assessment of structural flags)
- Assessment of current classifications for indicators of potential ED properties
- Scoping literature search assessing the volume of relevant published information
- Assessing the volume of available REACH registration data to estimate the workload for classification and full, detailed assessment
When to choose this service package?
- If you want to screen a bulk of substances for flags and early indicators of potential ED, PMT and PBT classification (before going for the full classification or assessment)
- When prioritising substances in the R&D cycle
- If you are hesitating whether more in-depth assessment is needed for your substance
Classification
Tier 2
typically €5.000-€8.000 per substance (depending on the volume of available information)
What does it take?
- Everything listed in the Rapid screening package
- Assessment of physico-chemical properties for PMT and PBT potential
- Assessing the robust study summaries within the existing REACH registrations
- Assessing your own unpublished data
- Screening published literature for additional relevant information
When to choose this service package?
- To follow your legal obligation under CLP – assessing the substance for ED, PMT and PBT properties and seeing whether the full, detailed assessment is needed in your case
Full, detailed assessment
Tier 3
typically €20.000-€50.000 (an accurate estimate can be provided upon rapid screening)
What does it take?
- All items listed in the “Rapid screening” and “Classification” packages
- Systematic literature review
- Assessment of available studies in line with the ECHA/EFSA guidance on endocrine disruptors with the listing of EATS pathways based on the Weight of Evidence assessment rules for categorization of individual lines of evidence
- Description of the identified effects with endocrine disruption potential in accordance with known Adverse Outcome Pathways (AOPs)
When to choose this service package?
- Best for industry consortia, associations of producers, groups of REACH registrants (ex SIEFs) when the costs can be shared
- When challenging other stakeholders with different classification (e.g. competitors with more severe classification, during public consultation on a proposal for harmonized classification (CLH) or when proposing harmonized classification), during a legal dispute over the classification)
Endocrine Disruption Basics: Prerequisites for the new ECHA Guidance on the Application of the CLP Criteria (FREE webinar)
The new ECHA Guidance on the Application of CLP Criteria is about to shake up the chemical industry with its heavy focus on endocrine disruption. Join Adam Jonas (REGARTIS) uncovering the basics of endocrine disruption.
Endocrine Disruption in CLP: First insights into the new ECHA Guidance (FREE webinar)
Adam Jonas (REGARTIS) and Ales Bartl (Keller and Heckman LLP) sharing their first impressions of the guidance.
Key Discussion Points:
- Content and scope of the new ECHA guidance
- Understanding the endocrine disruption criteria
- ECHA dealings with previous comments on guidance drafts
- Practical advice for chemical producers and regulatory affairs teams
Meet Adam.
Involved in this field since 2007, our ecotoxicology and toxicology expert Adam Jonas, Ph.D. started in academia performing experimental work to investigate the endocrine activity, acute toxicity, and neurotoxicity of various substances, mixtures, or environmental samples. He published several articles in leading toxicology and ecotoxicology journals. Later he had several regulatory roles in industry focused on biocides, plant protection, REACH, and CLP in the EU and other regions with proven track of successful registrations. He has experience with the endocrine disruptors assessment of plant protection and biocidal active substances under the current EFSA and ECHA guidance. He also helped design and study monitored numerous toxicological and ecotoxicological studies very often with very specific and difficult to be tested substances.
FAQs
Why should I act now?
The reason is simple. It is your legal obligation to assess your chemicals (substances and mixtures) for new CLP hazard classes, i.e. endocrine disrupting properties (ED), persistence, mobility and toxicity (PMT) and persistence, bioaccumulation and toxicity (PBT). And the deadlines are pressing!
1st May 2025: New classification and labelling is mandatory for SUBSTANCES
1st May 2026: New classification and labelling is mandatory for MIXTURES
What are these new CLP hazard classes?
Adam covered it all in his amazing webinars (see above), but to give you a quick overview, CLP Regulation recently introduced the following new hazard classes:
- ED HH in Category 1 and Category 2 (Endocrine disruption for human health)
- ED ENV in Category 1 and Category 2 (Endocrine disruption for the environment)
- PBT (persistent, bioaccumulative, toxic), vPvB (very persistent, very bioaccumulative)
- PMT (persistent, mobile, toxic), vPvM (very persistent, very mobile)
How can I check my duties on Endocrine Disruptors?
There are already several regulations in force, which you have to comply depending on the product you are placing on the market. First, you might need to check the appropriate regulation – besides of duties you are already aware of, there can be also new obligations on endocrine disruptors problematic.
Once you have defined your role and obligations, it is also important to follow the changes in these regulations and the ECHA`s Endocrine Disruptors list, as the information there can be updated.
For example, you can refer to ECHA`s Endocrine Disruptors assessment list, where substances undergoing the ED assessment are published and follow the status of the evaluation process and possible outcomes. One of the outcomes is that a substance is considered not to have ED properties. Another possibility is that the substance is considered to have those, meaning that the new legal requirements for the substance will follow.
You can also contact us to obtain an evaluation of your product and the obligations applied to you. Please check the section “How can we help you?” or contact us to receive a tailored service precisely for you.
Why it is important to address the issue of endocrine disruptors?
Firstly, you must comply to the EU laws, which makes you obliged to comply with the current regulations. For example, there are already obligation on Endocrine disruptors defined by REACH, CLP, BRP, Regulation on Cosmetics and Plant Protection Product regulation.
Secondly, we believe it is very important to make our planet a safe place for all of us. As endocrine disruptors cannot be completely removed or avoided, it is still possible to reduce the exposure and risks by screening, testing, and raising awareness on Endocrine disruptors' presence, which will contribute to a safer alternative search/safer world around us.
Contact us today to obtain the evaluation of your substances under the relevant guidelines and/or the complete compliance strategy and services for your products!
What are endocrine disruptors?
Endocrine disruptors (EDs) are chemicals that can impact human and animal health, interfering with their hormonal system. There are numerous adverse effects caused by those chemicals, as our body systems and functions are dependent on the hormones. Endocrine disruptors can be natural or man-made and may affect, for example, the nervous system, normal growth, physical and mental development, metabolism, reproduction, and other functions of our body.
Where can endocrine disruptors be found?
We encounter endocrine disruptors in everyday products, such as food packaging, toys, cosmetics, and plant protection products. The list is almost endless and includes things all around us – soaps, hair spray and nail polish, nonstick pans, textile coatings, and furniture foams. Even in some foods, endocrine disruptors can be found, such as phytoestrogens, which are present in certain edible plants and most abundantly in soy.
What regulations on ED are already in force?
Since 1999, the European Commission has had a strategy on Endocrine disruptors, which is taken into account by EU legislation revisions.
Nowadays, the PPP, Plant Protection Products Regulation and Biocidal Products Regulation provide the establishment of scientific criteria for substances with ED properties identification. Additional regulatory provisions for endocrine disruptors are covered under REACH, Regulation on Cosmetics, and EU legislation on food contact materials.
The harmonization of hazard-based criteria for endocrine disruptors identification is provided in the 7th EAP (Environment Action Programme), which was adopted in 2013.
Last, but not least, new hazard classes for endocrine disruptors were introduced by the Delegated Regulation on Classification, labelling and packaging of chemicals.
How will our cooperation and its outcome look like?
Depending on your specific case, we will define the following steps and services we can provide to make your product compliant with all the obligations concerning it. All received outcomes will meet the requirements of the relevant guidelines and regulations.
Do you have any more questions? Feel free to reach out to us for a consultation!