Distribution date: 29 May 2018 | Final date for Comment: 28 July 2018

The notified draft Resolution establishes the requirements and procedure for the registration with the ICA of homeopathic medicines for veterinary use. The draft text covers the following: Purpose; Scope; Definitions; Registration of homeopathic medicines for veterinary use; Labelling; Review of registration request; Procedures for issuing registration certificates; Issuance of registration certificates; Amendments to registration; Obligations; Prohibitions; Cancellation of registration; Authorization to import raw materials for the manufacturing of homeopathic medicines for veterinary use exclusively for export; Other provisions; Official control; Penalties; Transitional provision; and Period of validity.

Products Covered: Homeopathic medicines for veterinary use

Regulation Type: Regular notification

Distribution date: 29 May 2018 | Final date for Comment: 28 July 2018

This draft Circular specifies technical requirements for substances that are allowed to be added for vitamine A fortification in order to add more nutritional value into foods.

Products Covered: Vitamin A added in foods

Regulation Type: Regular notification

Distribution date: 25 May 2018 | Final date for Comment: 24 July 2018

The draft law in question provides mainly for the following: - The evaluation of phytopharmaceutical products in two different stages: · The first stage entails the evaluation and approval of active substances, safeners and synergists that may form part of the composition of phytopharmaceutical products; · The second entails evaluating and authorizing the placing on the market of commercial preparations containing previously approved active substances, safeners and synergists. - The placing on the market of products that pose a negligible risk to human or animal health or to the environment: · by introducing requirements that are less stringent than for other products; · by extending the period of validity for the approval and authorization of the placing on the market of the product to 15 years (as opposed to ten years for other products). - The re-evaluation, at any time, of products placed on the market, where information comes to light showing that the requirements on the basis of which the products were authorized are no longer being met, particularly as regards the products' effects on human and animal health and the environment; - The requirement that holders of phytopharmaceutical products notify any potentially harmful effects their products may have as soon as they become aware of them, and that the competent authority ensure the list of authorized products is made publicly available; - The establishment of requirements for conducting activities involving the import, repackaging, distribution and use of phytopharmaceutical products. These most notably include the requirement to provide proof of access to premises that meet the safety and hygiene standards set out in existing regulations, and the requirement to show that employees hold individual certificates issued upon the completion of a training course relevant to the activity they are required to carry out or on the basis of a diploma that they already hold; - The increased monitoring of trade in phytopharmaceutical products, so as to ensure compliance with the provisions of the law and the traceability of these products from the time they are imported or manufactured through to when they are used; - The inclusion of the settlement procedure, which will be applicable only for offences punishable by fine.

Products Covered: Produits phytopharmaceutiques

Regulation Type: Regular notification

Distribution date: 25 May 2018 | Final date for Comment: 22 July 2018

Its articles cover the following: Purpose; Scope; Definitions; Instruments for the management of chemical substances for industrial use; Register of chemical substances for industrial use; Obligation to conduct environmental and health risk assessments; Obligation to implement environmental and health risk reduction and management programmes; Environmental risk assessment; Health risk assessment; Environmental risk reduction and management programmes; Health risk reduction and management programme; Environmental monitoring of chemical substances for industrial use; Monitoring of the effects on health of the utilization of chemical substances for industrial use, Article 15. Intersectoral Follow-up Committee for the Management of Chemical Substances for Industrial Use (CISQUIN); Composition of CISQUIN; Functions of CISQUIN; Obligations of importers and manufacturers; Obligations of the marketers and distributors; Obligations of transporters; Obligations of users; Reliable data available; Mutual acceptance of data; Right to use information; Non-confidential information; Exchange of confidential information; Inspection, monitoring and control; and Period of validity.

Products Covered: Chemicals (28.00.00)

Regulation Type: Regular notification

Distribution date: 24 May 2018 | Final date for Comment: 23 July 2018

Proposed maximum residue limits (MRLs) for the following agricultural chemical. Pesticide: Methamidophos

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09);- Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08);- Products of animal origin (HS Codes: 05.04);- Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14);- Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14);- Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10);- Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08);- Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12);- Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06).

Regulation Type: Regular notification

Distribution date: 24 May 2018 | Final date for Comment: 23 July 2018

Proposed maximum residue limits (MRLs) for the following agricultural chemical. Veterinary drug/Feed additive: Semduramicin

Products Covered: - Meat and edible meat offal (HS Codes: 02.07 and 02.09);- Animal or vegetable fats and oils (HS Codes: 15.01).

Regulation Type: Regular notification

Distribution date: 24 May 2018 | Final date for Comment: 23 July 2018

Proposed maximum residue limits (MRLs) for the following agricultural chemical. Pesticide: Acephate

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09);- Dairy produce, birds' eggs (HS Codes: 04.01, 04.07 and 04.08);- Products of animal origin (HS Codes: 05.04);- Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14);- Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.05, 08.06, 08.07, 08.10, 08.11 and 08.14);- Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10);- Cereals (HS Codes: 10.05 and 10.06);- Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.07 and 12.12);- Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06).

Regulation Type: Regular notification

Distribution date: 22 May 2018 | Final date for Comment: 21 July 2018

This draft decision establishes clear and transparent models of acts necessary for the importation, storage and  production of plant protection products (pesticides, agri chemicals) and fertilizers. It provides simple models for the following acts:1. model of the notification about the importation of plant protection products and fertilizers;2. model of the notification about the manufacture of plant protection products and/or fertilizer;3. model of the notification concerning the request for validation and registration of specialized deposits for storing plant protection products and/or fertilizers;4. plant passport model.

Products Covered: Plant protection products (pesticides) and fertilizers

Regulation Type: Regular notification

Distribution date: 18 May 2018

On 15 June 2016 a draft legal act setting criteria to identify endocrine disruptors under the plant protection products regulation was issued by the European Commission (Commission). This proposal was notified in G/SPS/N/EU/166 on 20 June 2016. In December 2016, this draft legal act was split into two parts without any change in content: one text containing the criteria for identifying endocrine disruptors, and the other containing a proposed amendment to the derogation possibility based on negligible exposure. Information regarding developments in the legislative process was provided by the EU in G/SPS/GEN/1594 on 20 December 2017. The text containing the criteria for identifying endocrine disrupting properties for plant protection products was adopted as Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (Text with EEA relevance) [OJ L 101, 20 April 2018, p. 33]. On 2 May 2018 a Corrigendum – referring to the date of application – was published to Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties [OJ L 111, 2.5.2018, p. 10–10]. This Regulation shall apply from 10 November 2018.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 16 May 2018 | Final date for Comment: 15 July 2018

MPI is proposing the following options for management of myrtle rust in Myrtaceae seed lots:  Seed sourced from a country free from Austropuccinia psidii (formerly Puccinia psidii or Uredo rangelii), orSeed must be treated with one of the approved chemical treatments as per MPI Standard MPI-STD-ATBRT Approved Biosecurity Treatments. MPI recommends one of the following fungicides: Azoxystrobin, Triadimenol, Mancozeb, Triforine and Tebuconazole at maximum label rate.

Products Covered: Myrtaceae seeds for sowing

Regulation Type: Regular notification