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First applications

For first-time notifications, companies need to apply for a 5-digit applicant code. Authorities expect to issue codes to companies ca. 3 weeks after the application submission. The same code can be used for low and small volume substance notifications.

Requirements

Applications must include:

• company name and address;
• name of the responsible agent or notifier;
• volume, uses and chemical structure file with the help of METI’s MOL file check tool (view the guidance here);
• biodegradation studies and/or bioaccumulation studies.

With the exception of polymer flow scheme and physicochemical properties tests, test data need to be good laboratory practice (GLP) compliant.

Timelines

For the schedule overview, please refer to the attached file containing the  timeline details.

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The main changes which have been introduced in this up-to-date revision are the following:

• The new recommendation for the definition of nanomaterials which was published in 2022 by the European Commission (2022/C 229/01) has been introduced. This definition has not yet been applied to the definition of nanomaterial under the Cosmetic Regulation (EC) No 1223/2009. However, SCCS states that applicants should already take this new definition into consideration when preparing safety assessments for cosmetics containing nanomaterials since the revision of the Cosmetic Regulation is announced already.
• A detailed physicochemical characterization is important for the identification on nanomaterial. Therefore, in this revision descriptions for dispersion, solubility and dissolution rate, evidence for the absence of nanoparticles and aspect ratio were introduced. Also information on uptake, reproductive toxicity and endocrine disruption are given.
• Information on grouping and read-across and key aspects triggering a safety concern over a nanomaterial have been introduced.

The updated document should be used together with the general guidance “The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 12th revision, SCCS/1647/22” when assessing nanomaterials in cosmetics.

For detailed information, please refer to the guidance document.

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With the Chesar Platform project, ECHA aims at establishing a harmonised and IUCLID compatible reporting format based on a systematic assessment workflow with embedded exposure estimation tools.
To represent the needs and interests of all chemical risk assessment stakeholders involved, ECHA has initiated topic expert groups (TEGs) consisting of authorities, industry associations, companies and consultants. The TEG users are involved in discussions, providing their feedback on the proposed characteristics of the tool and actively participating in testing sessions to improve the usability of the new platform and detect its flaws and possible critical points.

After months of preparations, ECHA has announced its plans to introduce the “Alpha” version of the Chesar Platform in autumn 2023. Then, in-depth testing and adaptations based on user experience are planned before the first operative version as workstation and Cloud solution is scheduled for late April 2024.

As a member of the Chesar Platform stakeholder community, SCC is happy to contribute to the establishment of a harmonized and efficient format for the risk assessment of chemicals and biocides. We will keep you updated on recent developments of the Chesar Platform.
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1. CHESAR = CHEmical Safety Assessment and Reporting tool↑
2. EUSES = European Union System for the Evaluation of Substances↑

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By this call, EFSA intends to develop approaches to consider special substance properties or uses, for example reduced data collection for substances used as food or feed. In this context, EFSA put specific focus on semiochemicals, botanical active substances, other biological materials (like fermentation products of micro-organisms) and inorganic materials (such as minerals), although this list is non-comprehensive.

The proposals should help to identify circumstances where, from scientific point of view, only reduced data packages are required due to the nature of the active substance and its proposed uses. A further  objective is to develop a fit-for-purpose Environmental Risk Assessment (ERA) accounting for the specificities of these types of substances. In addition, EFSA has formulated a list of seven sub-objectives (e.g., development of science-based criteria for justifying the non-submission of guideline studies), as well as tasks and timelines related to the sub-objectives.

The complete duration of this project is scheduled for 18 months after the kick-off.  Competent organisations can send their proposals to EFSA until 15 September 2023.

Certain problems in the risk assessments or data requirements for potential low-risk substances, particularly those of biological origin, are already being discussed diversely on various levels. Inappropriate data requirements and risk assessments for such substances can reduce the economic interest of bringing low risk plant protection products to the market which would be a huge setback in reducing the use of chemical plant protection products under the EU Green Deal and the Farm to Fork strategy. Moreover, this can significantly reduce the farmers’ toolbox. The call for proposals by EFSA, therefore, is an important step to let the Commission adjust the regulations for these low-risk substances.

For more information on related topics such as low risk crop health active substances and products, please contact us.

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The extension periods also apply to self-declared CE marked Class I medical devices, as follows:

• Medical devices self-declared against EU MDR requirements – until 30 June 2030
• Medical devices, including unclassified devices and reusable surgical instruments, self-declared against MDD requirements before 26 May 2021 and requiring Notified Body involvement under EU MDR – until 30 June 2028
• Class I medical devices with a sterile or measuring function and a valid MDD certificate – until 30 June 2028.

The new legislation does not apply to the following medical devices which cannot be placed on the market in Great Britain after 30 June 2023:

• Custom made devices compliant with the EU MDD or AIMDD
• Class I medical devices and general IVDs under the Directives, for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body.

For further details on the new timelines, please refer to the MD Amendment Regulations 2023, its summary or view the explanatory infographic provided by the UK government.

The UK government also intends to introduce further provisions later in 2023 to reinforce post-market surveillance requirements which are expected to apply from mid-2024.

1. EU MDD = the EU medical devices directive↑
2. EU AIMDD = the EU active implantable medical devices directive↑
3. EU MDR = the EU medical device regulation↑
4. EU IVDD = the EU in vitro diagnostic medical devices directive↑
5. EU IVMDR = the EU in vitro diagnostic medical devices regulation↑

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Since an evaluation of large databases including REACH registered data is showing cumulative risk levels exceeding a risk characterization ratio (RCR) of 1, the adoption of the mixture assessment concept is proposed as a pragmatic and precautious default assumption. The risk management tool MAF should be applied in the CSR, when a specific risk assessment considering all (relevant) substances, to which human populations and the environment are exposed, is not possible.

A default MAF of 5 is proposed, which should be applied to substances registered at ≥1,000 t/y (covering >99.8% of total tonnage registered), and which should also be utilized to establish DMELs (Derived Minimal Effect Levels) for non-threshold carcinogens and mutagens without new animal tests. The MAF will be relevant for eco- and toxicological risk assessment. A derogation from the default MAF is possible if a specific risk assessment is carried out and documented. The respective clause of the REACH regulation Article 138 will be reviewed.

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As a first step, notification will be required for all EU manufactured or imported polymers above 1 tonne per year – both PRR and non-PRR. This step intends to map the vast polymer universe. Limited information on the polymer will be required for their notification – more information for PRR and less information for non-PRR. The overview of polymers on the EU market shall allow the definition of grouping criteria. Grouping of the polymers will be crucial to handle the extensive registration needs of PRR. A grouped registration of several similar polymers relies on the assumption of hazard homogeneity with a common set of information obtained from one or more test substances.

In a second step, registration of PRR will be required. The information requirements for the registration will depend on the molecular weight (MW) for the polymers. There will be an assignment to three different types of polymers:

Type 1: low MW polymers
Type 2: medium MW polymers
Type 3: high MW polymers

While Type 1 polymers are expected to have the same information requirements as non-polymeric substances, the information requirements for Type 2 and Type 3 polymers will be very limited. Also under discussion is an exemption from the registration requirement for polymeric precursors, i.e. polymers used to produce other polymers or articles.

The revised REACH proposal, to be presented by the end of the year, will contain the basic provisions for polymers. The exact details of the registration of PRR, such as the information requirements, are unlikely to be part of this proposal. They will be amended as part of the new annex a few years later.

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Increased Information Requirements for Human Health

• Neutral Red Uptake Assay

• in chemico protein binding (e.g. fraction unbound in human plasma)
• in vitro human hepatic clearance (e.g. isolated human hepatocytes)
• in vitro intracellular bioaccumulation (e.g. in Caco-2 cells)
• in vitro intestinal absorption (e.g. Caco-2 permeability)

• Estrogen receptor transactivation assay (OECD TG 455)
• Androgen receptor transactivation assay (OECD TG 458)
• H295R steroidogenesis assay (OECD TG 456)
• Aromatase assay (OPPTS 890.1200)

For substances that raise concerns, triggering testing for repeated dose toxicity and screening for reproductive/developmental toxicity (OECD TG 422) and in-vivo tests on endocrine disruption would be considered. Inter alia, the following options for triggers are under discussion: Trigger based on biological half-life predicted from log Kow (>3) or trigger based on in-vitro toxicokinetics data (to be generated only after this revision).

The triggers/waivers are still under discussion.

The proposed additional requirements if there is a concern for ED are: Uterotrophic Bioassay in Rodents (OECD TG 440) and Hershberger Bioassay in Rats (OECD TG 441).

To update the requirements to scientific progress and to balance the additional requirements at low tonnages and for EDs, the following studies are proposed to be deleted:

- acute oral toxicity in rats (Annex VII)
- acute dermal & inhalation toxicity in rats (Annex VIII)
- skin corrosion/irritation (Annex VIII)
- serious eye damage/eye irritation (Annex VIII)
- assessment of the toxicokinetic behaviour to the extent that can be derived from the relevant available information (Annex VIII)
- further studies beyond the 90-day study (Annex IX column 2)
- pre-natal developmental toxicity study 2nd species (Annex X and trigger in Annex IX)
- long-term repeated toxicity study (≥ 12 months) (Annex X)
- tentatively: carcinogenicity study (Annex X)?

The scope of studies that may be deleted and the conditions for deletion are under discussion.

Increased Information Requirements for Environment

For the environmental data requirements, the following proposals were presented:

- Replacing short-term fish toxicity test and bioaccumulation in fish with in vitro tests
- Long-term toxicity testing on invertebrates (Daphnia): move them from Annex IX to Annex VII
- Triggers/waivers: are under discussion
- Additional requirements for ED identification: are under discussion

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The MDR and IVDR were amended by Regulation (EU) 2023/607 (entered into force on March 20, 2023) which led to the extension of the transition period and the deletion of the “sell-off dates”.

Regulation (EU) 2023/607 provides for the extension of certain Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) certificates.

Notified bodies use the new EC form to confirm that the manufacturer (including the devices concerned) meets the requirements of Regulation (EU) 2023/607 and is therefore eligible for the extended transition period.

For competent authorities, healthcare professionals, users, authorised representatives and markets recognising CE marking, this form, completed by a notified body, is very helpful in determining whether devices can still be legally placed on the market with MDD or AIMDD certificates.

Essential conditions for a renewal:

• No unacceptable risk to health or safety
• No significant changes in design and intended use
• Continuous compliance with the (AI)MDD
• MDR compliant quality management system (QMS) established by May 26, 2024
• Conformity assessment application submitted by May 26, 2024 and agreement signed by the manufacturer and a notified body by September 26, 2024.

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This is a rare example of a public-private partnership, since the industry will not only be asked to share the available data with the government, industry representatives will also be invited to participate in the data review and decision making for the target substances. On the part of the Japanese government, several authorities are participating in the project, including the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), the Ministry of the Environment (MOE), Japan's National Institute for Occupational Safety and Health (JNIOSH) and the National Institute of Technology and Evaluation (NITE).

While there is no obligation for businesses to actually include the same information on their labels and SDSs for a substance, GHS classification results by the government are intended to be used as a reference for businesses to create compliant labels and SDSs. In Japan, however, there are three main chemical laws (ISHL, PRTR and PDSCL)* that all refer to GHS-compliant SDSs and labels, each with different regulatory requirements. GHS-compliant SDSs and labels need to comply with JIS Z 7252 and 7253, based on GHS (Rev.6). The authorities are preparing an update to GHS (Rev.9).

The deadlines communicated on 18 April 2023 for industry participation are as follows:

• Declaration of intent (‘enrollment’): by 30 June 2023
• Submission of data and information: by 31 October 2023

The list with the 157 target substances for 2023 can be found on the official website of the National Institute of Technology and Evaluation (NITE).

*       ISHL: The Industrial Safety and Health Law

PRTR: The Pollutant Release and Transfer Register

PDSCL: Japan's Poisonous and Deleterious Substances Control Law (Japanese only)

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According to Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices,  certificates issued by notified bodies under Directives 90/385/EEC and 93/42/EEC (AIMDD and MDD) after 25 May 2017 and still valid before 26 May 2021 shall remain valid after the end of the period indicated on the certificate until:

• 26 May 2026 for class III custom-made implantable devices;
• 31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
• 31 December 2028, for class IIb devices other than those mentioned above, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.

However, this only applies on the condition that the devices continue to comply with the AIMDD or MDD and there are no significant changes in the design and intended use. Furthermore, no later than 26 May 2024, the manufacturer (or the authorised representative) has lodged a formal application with a notified body in accordance with Annex VII MDR for conformity assessment, and the notified body and the manufacturer have signed a written agreement for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device before the date of expiry of the certificate.

Another requirement for the extension of the transition period is the establishment of a quality management system by the manufacturer no later than 26 May 2024, in accordance with MDR Article 10(9).

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The key elements of the proposal are:

• For medical devices covered by a certificate or a declaration of conformity issued before 26 May 2021, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
• The proposal introduces a transition period until 26 May 2026 also for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before 26 May 2024.
• To reflect the transition periods put forward by these amendments, the proposal extends the validity of certificates issued up until 26 May 2021, the day when the Medical Devices Regulation became applicable.
• The Commission also proposes to remove the ‘sell-off' date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation. The ‘sell-off' date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off' date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need.¹