New Manufacturer Incident Report templates for medical devices available

Date: 13 February 2019

The European Commission has published a new Manufacturer Incident Report (MIR) template, which adopts the Medical Device Regulation MDR (EU) 2017/745. The new template replaces the form in MEDDEV 2.12/1 revision 8 annex 3 and has been restructured and extended in all sections.

Further to the reporting template, a detailed help text is provided, including the tables for the code selection as well as the .xsd files for implementation in the manufacturer’s databases before January 2020.

Click on the following links to download the files:

SCC launches a new regulatory group – Medical Devices

Date: 23 January 2019

Medical Devices Dr Alexander Theis

We are happy to announce that we have recently launched a new regulatory group within our Chemicals division to expand the range of our services to registration support for the medical devices industry.

The new group is headed by Dr Alexander Theis, a polymer chemist with a hands-on long-standing experience in the medical device industry.


Our services for medical devices currently include:

  • Offering support in product development and in-market compliance
  • Individual gap analysis in context of MDR (EU) 2017/745 requirements
  • R&D support
  • Providing guidance with regard to biological evaluation of medical devices in line with ISO 10993
  • Literature search and supply service
  • Clinical evaluation following Article 61 and Annex XIV MDR (EU) 2017/745 and MEDDEV 2.7/1 revision 4
  • Qualification and validation of production and quality control equipment and methods
  • Preparing Safety Data Sheets

UK releases further guidance on chemicals regulation in the event of a no-deal Brexit

Date: 23 January 2019

In light of recent events, the British government has published further guidance covering the legal requirements included in the Biocidal Products Regulation, Classification Labelling and Packaging and Prior Informed Consent regulations as retained in UK law, using powers in the EU Withdrawal Act 2018. To view the recent requirements in case of a no-deal Brexit, please download the following files:
Guidance on Biocidal Products Regulation (BPR)
Guidance on Classification Labelling and Packaging (CLP)
Guidance on Prio Informed Consent Regulation (PIC)

Constantly keeping your REACH dossiers up-to-date: this is NOT a ‘nice-to-have legal option’

Date: 17 January 2019

Recent communication by the EU Commission, ECHA, the BfR, and also by Cefic all emphasized the high importance for systematic REACH dossier updating by the registrants.

We have summarized the most important facts for you in one file which you can download here.

Don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it. learn more.

Implementing Regulation on registration updates

Date: 8 January 2019

In the course of the 28th Meeting of Competent Authorities for REACH and CLP (CARACAL) the European Commission published a document (CA/114/2018) regarding the scope of an Implementing Regulation on registration updates.


The Commission is of the opinion that an Implementing Regulation would clarify for all actors under REACH how the duties concerning dossier updates as referred to in Article 22 should be understood in more detail. Especially, how the timing indication “without undue delay” should be understood in the context of the different cases requiring an update, and to provide clarification on the actual trigger for the updates where required.

The Commission proposes the following timeframes for the different scenarios as given in REACH article 22.

Changes triggering updates as per Article 22 (1)




(a) any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address


Within 6 months
(b) any change in the composition of the substance as given in Section 2 of Annex VI

Within 3 months for substance composition if the new composition is covered by current joint submission

Within 1 year if updated CSR or new Classification & Labelling, triggered by composition change

Within 6 months after the completion of any additional study needed based on composition change but where results do not trigger C&L or CSR changes


(c) changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import

Quantities should be reviewed at least once a year.
If quantities changed or manufacture or import ceased, updates shall be done:
- Within 3 months if the change in tonnage band relates to a decrease in tonnage band or an intermediate use under strictly controlled conditions
If change of quantities trigger higher tonnage band:
- submission of testing proposal within 6 months for update of tonnage band leading to Annex IX or X requirements
- within 6 months after the completion of any additional study needed at Annex VII or when increasing to Annex VIII, and latest within 2.5 years after the end of the calendar year in which the tonnage threshold was reached or exceeded


 (d) new identified uses and new uses advised against as in Section 3.7 of Annex VI for which the substance is manufactured or imported

Within 3 months for registrations not requiring a CSR or if current CSR is concluded to cover new use(s)
Within 1 year for registrations requiring a CSR where the current CSR does not cover new use(s)


 (e) new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report


 Within 1 year
 (f) any change in the classification and labelling of the substance

 Within 1 year


 (g) any update or amendment of the chemical safety report or Section 5 of Annex VI

 Within 1 year


 (h) the registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal shall be developed


 Within 6 months
 (i) any change in the access granted to information in the registration  Within 6 months


The planned Implementing Regulation is in connection with the announced change that ECHA will no longer inform registrants or grant a chance for dossier updates prior to regulatory measures, starting 1 January 2019. It is the declared intention of the Commission and ECHA that in case of a compliance check or dossier evaluation the registrant needs to defend the dossier as it is. ECHA stressed that it is the registrant’s duty to keep the dossiers up-to-date (e.g. remove or add uses) and not to file updates upon incident. Please also check our news item regarding changed compliance check procedure from January 2019 onwards for more details.

After seeking stakeholder input following the November CARACAL meeting, the Commission plans to bring a proposal for an Implementing Regulation to the REACH Committee in February 2019. After a first discussion of the legal text at this meeting, the Commission plans to bring it back for a vote in April 2019. Thus, it may be possible that the Implementing Regulation will enter into force already in 2019.

SCC has a lot of experience in preparing and updating REACH dossiers according to the current REACH requirements. In case you are planning to update your REACH dossiers we can provide you with support. Please get into contact with This email address is being protected from spambots. You need JavaScript enabled to view it..

SIEF / SIEF Agreements

Date: 7 January 2019

The EU Regulation on chemicals “REACH” (Regulation (EC) No. 1907/2006) stipulates that Substance Information Exchange Forums (SIEFs) had to be operational until 1 June 2018, the day after the last REACH registration deadline.
Nonetheless, the registrants of a substance are still bound by the obligation to submit the information on their substance jointly and as of 1 January 2019, co-registrants have to coordinate the reply to ECHA, and speak with one voice during the entire process if they receive an ECHA decision, due to testing proposal evaluation or incompleteness of their dossiers.


History: The aim of the SIEFs was to help the registrants of the same substance to cooperate with regards to exchange of chemical substance data required for joint registration and so to avoid unnecessary testing, especially on animals and – if possible – to agree on C&L.

But what about the future of the SIEFs and SIEF(-based) Agreements?

In many cases the contractual cooperation basis for co-registrants, the “SIEF Agreement”, was terminated on 1 June 2018. Moreover, SIEF Agreements that are still in place often do not fully comply with the regulation on joint submission and data sharing (Commission Implementing Regulation (EU) 2016/9), which came into force several years after many contracts had been prepared.

However, the legal obligation to cooperate among the co-registrants for the joint registration and for data sharing related tasks persists. This cooperation, e.g. on managing update needs and updates of the registration dossiers (Article 22, REACH), as well as coordinated responses to potential regulatory requests related to dossier and substance evaluation, might become more intensive, depending on the regulatory and scientific issues that might arise and which – as of 2019 – ECHA will address to all non-compliant registrants (no longer mainly to the LR) of a substance.

Furthermore, the dynamic of EU chemicals market, political decisions such as BREXIT, etc. require ongoing data management and lead registrants who should be prepared for cost sharing requests of new registrants and reimbursements to existing registrants.

Even if the number of co-registrants per substance is lower than the number of SIEF members (some SIEFs now comprise hundreds or even thousands of members), the administrative burden and time for communication should not be underestimated.

Considering all the tasks mentioned above, amendments to existing contracts might be necessary or – as recommended by The Directors’ Contact Group – “SIEF Agreements” should be replaced by new cooperation contracts, addressing the “after-deadline” obligations and ensuring compliance with the available regulations.

ECHA Accounts - new features

Date: 7 January 2019

ECHA has launched new services for users of ECHA accounts.
When you log into your ECHA account, you now have the possibility to link the substances that are important for you and your company directly to your ECHA account by selecting them from the "Search for chemicals" section.


Once you have added the substances to your "My Substances" list, you will receive a weekly notification as soon as one of your substances is included or updated in one or more of the following five regulatory procedures (multiple choice is possible):

  • Registration dossier update alert
  • Substance Evaluation update alert
  • Candidate List alert
  • Authorisation process alert
  • Restriction process alert

You can also save and reuse your searches without having to fill out the form again. At there is a short tutorial that is very helpful and will guide you through these new features.

With your ECHA account you can also download the IUCLID software, the Chesar tool, become part of a future poison centres community and subscribe to the corresponding news for all these applications.

Any ECHA account you have already created to access an ECHA IT tool (i.e. REACH-IT, R4BP 3, ePIC) can be used to log into ECHA’s main webpage. If you have not yet created an ECHA account you must log in first. The latest version of the "ECHA Account Manual (November 2018)" will guide you step by step and help you to set up. The pdf is available at under the heading „Signing up“.

ECHA introduces changes to the compliance check process as of 1 January 2019

Date: 19 December 2018

In the course of the 27th Meeting of Competent Authorities for REACH and CLP (CARACAL) ECHA published a document (CA/63/2018) concerning the changed dossier evaluation and compliance check on 12 June 2018. The introduced changes will be effective from 1 January 2019.


ECHA has critically reviewed the current process and based on the experience of the past ten years decided to introduce some changes. As a major change ECHA will extend the scope of the compliance check to all relevant dossiers within a joint submission. In particular, this will affect the following most important points:

  • In the future, ECHA will firstly check the lead dossier, and, if present, the boundary composition. Subsequently, ECHA will screen the members’ dossiers to identify whether the composition is consistent across the joint submission (and consistent with the substance identity profile, SIP) and whether deviations may impact the hazard assessment.
  • Partial or full opt-out dossiers will be assessed at the same time as the data submitted jointly. This will result in a separate decision addressed only to the relevant opt-out registrants.
  • CSR related issues will no longer be included in the draft decision unless the CSR is jointly submitted and the request refers to completeness in the sense of e.g. missing exposure assessment or missing exposure scenarios.
  • Once a draft decision is issued, registrants will need to comply with the requests in the decision according to the tonnage declared when receiving the draft decision. It will no longer be possible to change the tonnage band or the type of registration (full vs. intermediate) as soon as a draft decision is issued by ECHA. ECHA will no longer consider second attempts made for waiving an endpoint (e.g. a new read-across) via dossier update during an on-going compliance check procedure.
  • As a general rule, ECHA will no longer offer an informal communication to the registrants after the draft decision is issued.
  • ECHA will stop publishing a list of substances which are potentially candidates for compliance check.

ECHA strongly highlighted that “as the phase-in registration period is now over, registrants should shift their attention to the quality of their dossiers and update them without undue delay, as stipulated in Article 22.” Subsequently, ECHA expect that registrants comply with their obligation and ECHA will consistently apply its expectation in the dossier evaluation process.

Thus, ECHA is expecting dossiers to be up-to-date and will not inform registrants or grant a chance for dossier updates prior to regulatory measures.
In light of the planned changes, ECHA strongly encouraged registrants to take a pro-active role, to review the dossiers and update them, if necessary, without waiting for an alert or a draft decision.

SCC has a lot of experience in preparing and updating REACH dossiers according to the current REACH requirements.

In case you are planning to update your REACH dossiers we can provide you with support. Please get into contact with This email address is being protected from spambots. You need JavaScript enabled to view it..

Essential aspects of the 2nd REACH review from the point of view of the BMU

Date: 19 December 2018

On 6-7 December 2018 the BAuA REACH congress 2018 took place in Dortmund. In the introductory presentation, Dr Axel Vorwerk, ministerial official at the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety in Germany (BMU*), outlined the essential aspects of the 2nd REACH review from the point of view of the BMU.


Among other things, he presented the positioning of the Federal Government in the priority area of data quality as follows:
Ensuring dossier conformity is a major concern for the authority.
•    The reliability of the data basis is crucial for the benefit of REACH, also for the economy itself.
•    Experience has shown that in many cases the registration data submitted are insufficient to varying degrees.
•    The BMU’s aim is for the registration dossiers for all substances to be reviewed within a manageable period of time, i.e. in the next ten years. This would require a significant multiplication of the number of dossier evaluations per year.
•    Furthermore, it must be ensured that the database is not obsolete (e.g. changed use/exposure).

Dr Vorwerk presented the following measures to improve the data quality:
•    Significant streamlining of evaluation procedures. Until now, it usually takes several years for missing data to be submitted or for erroneous data to be corrected.
•    Substantially increase the administrative resources used, including discussing how registrants should share the costs and what incentives should be put in place to ensure that information is provided in the required quality from the outset.
•    The Commission could examine measures to improve own-initiative updating under Art. 22 REACH and could also consider the question of regular updating requests.

The most remarkable statement is that the German authority aims to evaluate all REACH dossiers within the next 10 years. This is of course currently not an agreed position between member states but should raise attention in industry.

The position of Germany again emphasises that REACH is not done after the last registration deadline has passed. You should stay tuned and plan your capacities for dossier updates and substance/dossier evaluation accordingly.

To find out more details, please download the presentation (only in German available).

*Federal Ministry for the Environment, Nature Conservation and Nuclear Safety in Germany (BMU)

New SCC Service on eSDS: Translations into all European Languages implemented

Date: 18 December 2018

When a risk assessment according to REACH Article 14 or 37 has been conducted for a registered substance, the corresponding exposure scenarios as well as risk management measures (RMMs) have to be communicated to the downstream users (DU) by providing an extended Safety Data Sheet (eSDS; REACH Art. 31 (7)). This eSDS must be made available in the respective official language of the member state in which the substance is marketed (REACH Art. 31 (5)). Thus, translating eSDS is a crucial step for Registrants in order to fulfil their duties under REACH. In the past no tool was available providing an automatic translation of the Annex to an eSDS containing the exposure scenarios.
With Chesar, one of the most widely used tools for risk assessments, an eSDS can be easily prepared for a substance – however, only in English.
SCC has now implemented a new service that allows translations of eSDS into all European languages with Chesar. The only prerequisites for this service are:

  • A risk assessment for the corresponding substance in Chesar is available
  • Harmonized phrases according to ESCom are applied to describe uses and their RMMs

Of course, both of the above are well-established services of SCC as well.
Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. or your direct SCC partner to learn how easily you may get ready with your eSDS translations.

Improving the workability and quality of extended Safety Data Sheets

Date: 18 December 2018

In the course of the recent meeting of the competent authorities for REACH and CLP (CARACAL) the member states, the Commission, ECHA and stakeholders discussed how to improve the workability and quality of extended Safety Data Sheets.
The Safety Data Sheet is a mandatory tool for suppliers of hazardous chemicals (substances and mixtures) to provide the users with safety-relevant information. For substances that require a Chemical Safety Report to accompany the registration dossier, the corresponding Exposure Scenarios (ESs) extend the traditional Safety Data Sheet (SDS) to an extended SDS (eSDS), with information on use- or task-specific conditions of safe use.
ECHA has identified a number of root causes that affect the workability and quality of the extended safety data sheet.


  • The legal text and ECHA guidance leave it open how exposure scenarios of substances are to be included into the mixture safety data sheet (SDS).
  • There is no common understanding whether an SDS for a mixture should have an exposure scenario (ES) Annex like the substance-related SDS, and whether users of mixtures have downstream users’ duties under REACH.
  • Similarly, the relationship between the ES Annex and Sections 7 and 8 of the SDS is not clearly described in Annex II of REACH, and thus leads to difficulties for recipients of an SDS to identify the information needed for checking their conformity.

The lack of harmonisation/standardisation regarding the data format of the extended SDS prevents the transfer of data in a way that IT systems could directly process the information received. As a consequence, at the moment, all information is to be uploaded manually into tools for processing (when they exist), which consumes a lot of resources and is error prone.

In addition, there is no common assessment standard supporting all the expected processing of safe use information through the supply chain by the various actors. IT providers have developed a variety of solutions for some of the tasks (mainly based on the clearly enforceable duties). The language of the Annex to the safety data sheet is an illustrative example, easy to check for inspectors but coherent translation is very challenging for IT providers.

The Commission (COM) and ECHA thus called for feedback regarding the experience with current (harmonised) formats and IT tools. Afterwards COM and ECHA will organise a workshop to make proposals for follow on work. The Commission considers including minimum requirements for the exposure scenarios for substances and mixtures in Safety Data Sheets and requesting ECHA to develop a methodology for Safety Data Sheets for mixtures. The results thereof and possible implementation in the legal text may require years. Until then the current status remains.

The Exchange Network on Exposure Scenarios (ENES) has developed harmonised formats and IT tools (e.g the EuPhraC catalogue for standard phrases). However, uptake and use of the ENES tools remains limited.
Within this context please refer to our news item regarding eSDS translation.