Commission clarifies its position on registration obligations regarding cease of manufacturing before the 2018 deadline

Date: 27 April 2018

In SCC’s last newsletter we reported about the Commission’s position on phase-in status after May 2018 with a special focus on Commission’s interpretation of registration obligations.

On 4 April, the Commission provided a clarification on its statement. The intention of the statement was to confirm that, regardless of whether a manufacturer or importer of a phase-in substance ceases to manufacture or import after the deadline, he will have to register. This differs from the scenario described by the Germany CA which focuses more on the scenario before the registration deadline.

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Consequently the commission modified the wording of its statement as follows:
“[…] the Commission wishes to clarify that if a manufacturer or importer of a phase-in substance, who has pre-registered that substance, exceeds the 1 tonne per year threshold in 2018, based on the 'three-year average' rule in Article 3(30), but has ceased the manufacture or import of that substance before the final registration deadline on 1 June 2018, then he will not be required to register after the deadline has passed unless he subsequently restarts the manufacture or import of the substance and the conditions of Article 6 of REACH are met.”

Taking this updated statement into account the Commission’s interpretation is in-line with the interpretation of the national helpdesk, ECHA’s F&Q and the ECHA guidance documents.

We would like to point out that one should closely monitor the manufacturing / import of substances until the deadline in order to ensure that no import or manufacturing takes place after 31 May 2018 which results in an overall tonnage above 1 tpa. Please keep in mind that the time point for import is the arrival of the shipment at the European customs clearance.
In case you have any questions or need further support, please get into This email address is being protected from spambots. You need JavaScript enabled to view it. with us.

Dr Thomas Roth, Head of Chemicals/REACH, Consumer Products, Cosmetics, Feed & Food Additives
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EPA Interim Science Policy for the Replacement of Animal Testing for Skin Sensitisation

Date: 27 April 2018

On 10 April 2018, EPA published a draft of an Interim Science Policy to reduce animal testing for skin sensitization, which can be found here. The draft of the Interim Science Policy is open for public comment until June 9, 2018.

The draft document states that the Office of Pesticide Programs (OPP) and Office of Pollution Prevention and Toxics (OPPT) will immediately begin to accept submissions as described in the draft Science Policy.

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It lists OECD test guidelines that will be accepted in submissions to the Agency for single chemicals. For the time being, alternative testing will be accepted only for pesticide active and inert ingredients, but not yet for formulations. However, the agency states that it expects expansion of this interim policy in the near term to include some pesticide formulations or other mixtures evaluated by OPPT.

In contrary to the situation in Europe where a clear guidance for the regulatory interpretation of the alternative method is still pending, EPA has defined clear criteria how the results of the alternative test methods should be handled.

The two following defined approaches (DA) will be accepted by EPAs as alternatives to the LLNA for regulatory submission:

  • Adverse Outcome Pathway (AOP) “2 out of 3”
  • Key events (KE) 3/1 sequential testing strategy (STS)

The first DA was initially submitted to OECD by BASF and reflects the current approach used for the non-animal test strategy in the scope of EU REACH (SCC Comment: The “2 out of 3” approach is not yet officially confirmed by ECHA): At least two studies need to be conducted in order to assess two different key events. If these studies provide discordant results, a study for a third key event needs to be performed. The overall result is based on the two concordant findings. In case two positive findings are revealed this leads to a conclusion as sensitizer.

The second DA reflects a simple decision tree that requires only two studies. The first study investigates the key event 3 (Dendritic cells). If the response is positive, the test substance is classified as a sensitizer. If a negative result is obtained from a key event 3 assay, an assay for key event 1 (covalent interaction with skin proteins) is conducted. A negative study for key event 1 confirms that it is a non-sensitizer and a positive result for key event 1 leads to a finding of sensitizer.

A project proposal was submitted to OECD jointly by the US, EU, and Canada to develop a new performance-based test guideline (PBTG) for defined approaches for skin sensitization. As part of the work on the future OECD PBTG guideline, refinements and updates to some of the defined approaches are expected in the near-term (until end of Q4 2018).

SCC's conclusion is as follows: In case companies already generated data for skin sensitisation for chemicals subjected to registration under REACH using the “2 out of 3”, these data will be accepted by EPA and thus additional animal studies do not need to be conducted in order to comply with US data requirements in the near future.

Dr Thomas Roth, Head of Chemicals/REACH, Consumer Products, Cosmetics, Feed & Food Additives
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European Parliament adopts new regulation on Europe’s organic agriculture

Date: 24 April 2018

On April 19th European Parliament has adopted the new legislation on EU organic farming rules thus repealing Regulation 834/2007. The new regulation, initiated in 2014, was adopted with 466 votes against 124.

As the organic farming sector has hugely grown in the last years, organic managed farms covering 6.7 % of Europe’s agricultural area (2016, EU-28), the new Regulation tries to adapt the regulatory framework for organic farming to these new circumstances and establish the basis for the further growth of this farming sector.

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Advancement of organic farming is already well established in different political and regulatory frameworks, such as the Common Agricultural Policy (CAP) or the Directive for sustainable use of pesticides (SUD  2009/128). To further boost organic farming in EU the new Regulation allows for a mixed production of organic and conventional food on one holding and simplifies the certification for small farmers (group certification) to encourage conversion.

Furthermore, the new Regulation implements strict, risk-based checks along the organic supply chain and phases out the current “equivalence” rules for imports of organic goods within five years after entry into force.


In regards to plant protection, “the new rules are not very different from the current legal situation” says rapporteur MEP Martin Häusling. Main focus is to avoid contamination from chemical pesticides or synthetic fertilisers. In order to further improve respective standards, a new set of measures is implemented by the Regulation. Effectiveness of these new EU anti-contamination rules and national thresholds will be checked four years after entry into force of the new regulation and if need be the Commission is to come up with a draft law to harmonise them. For further information on pesticide residues in organic food see also the supporting publication by European Food Safety Authority, 2018: Monitoring data on pesticide residues in food: results on organic versus conventionally produced food. EN-1397. Click here to view EFSA's publication.

Read also the Provisional Edition of the European Parliament legislative resolution of 19 April 2018 on the proposal for a regulation.
Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM _______________________________________________________________

Commission publishes new rules on transparency and sustainability of the EU risk assessment in the food chain

Date: 24 April 2018

In April, Commission published its proposal for a new regulation to improve the transparency and sustainability of EU risk assessments for plant protection products, GMOs (cultivation, food/feed uses), feed additives, food contact materials, food additives, food enzymes and flavourings, novel foods and smoke flavourings (COM(2018) 179 final). The new Regulation is a follow-up of the fitness check of the General Food Law Regulation (Regulation 178/2002), initiated in 2014, and the Commission's reply to the European Citizens Initiative ‘Ban glyphosate and protect people and the environment from toxic pesticides’.

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The aim of the proposal is to ensure more transparency on safety related information used for risk assessments for substances and products used in the food production chain (regulations to be amended see below) by:

  • Ensuring for public access to all relevant information
  • Establishing a common European Register of commissioned studies for all regulatory frameworks in the food chain
  • Possibility for additional studies to be requested by EFSA and financed by EU budget
  • Consultation of stakeholders and the public on studies submitted in the registration process
  • Increase Member States' involvement in the European Food Safety Authority's (EFSA) governance structure and scientific panels
  • Strengthening risk communication to citizens
Confidentiality of studies/information provided in the registration process will be maintained. The new Regulation will contain a positive list of confidential items to safeguard commercial interests of applicants.
As the fitness check on the General Food Law Regulation has also shown that the approval/authorisation procedures for several sectors are long-lasting and thus slow down the market entry process of the respective products, a closer involvement of EFSA, for example in the pre-submission procedure, may contribute to a faster and more streamlined registration process.
Vytenis Andriukaitis, the European Commissioner for Health and Food Safety called for a fast entry into force of the new Regulation, i.e. early 2019, whereat for specific issues, such as the expansion of the Management Board specific timelines are set in the Regulation. 

Amended Regulations/Directives:

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM
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ECHA’s news: Mastering challenging chemical risk assessments using Chesar

Date: 15 February 2018
Dr Thomas Roth, Head of Chemicals / REACH, Consumer Products, Cosmetics, Feed & Food Additives

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Another warning notice to stakeholders issued by European Commission on 23 January 2018

Date: 25 January 2018
 
In this renewed warning, the EU Commission stated:

“Concerning submissions of new applications, business operators should take into account the expected timelines of different regulatory procedures in which the United Kingdom would be acting as, for example, rapporteur Member State, zonal rapporteur Member State or evaluating Member State for MRLs. Taking account of the aforementioned uncertainties as well as the regulatory framework, business operators should consider taking the relevant actions. For example, where there is a risk that those procedures are not concluded by the date when the United Kingdom will leave the Union, applicants may choose by preference another Member State to carry out the evaluation or assessment.

Concerning those on-going procedures for which the United Kingdom is currently carrying out an assessment or evaluation, business operators should carefully monitor their progress. Where there are clear indications that the procedure will not be concluded by the withdrawal date, taking account of the uncertainties as well as the regulatory framework, business operators should consider taking the necessary actions. For example, a change of rapporteur or evaluating Member State may be required.“ 

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In addition to that warning message, EU Commission published a question and answer document on the Brexit. In this paper, important questions on, for example UK company locations and UK manufacturing sites are addressed.

Click here to find the full text of the European Commission notice and here for the related document.

You may also refer to the corresponding link: https://ec.europa.eu/food/plant/pesticides_en

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New head of Biocides business unit starting in January 2018

 

Martina Galler has a PhD in biology and more than 15 years of experience in biocides regulatory affairs. She currently heads up the preservatives group within SCC’s Biocides business unit and will take up her new role at the beginning of 2018. Martina’s field of expertise comprises all BPR activities relating to biocidal active substances and products as well as the environmental risk assessment of biocides in nearly all product types.
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