Regulatory Updates

Distribution date: 29 October 2013 | Final date for Comment: 28 December 2013

The document introduces amendments to CU legislation specially to the CU form of veterinary certificate No. 36. The document adjusts veterinary certificate with the relevant Common veterinary requirements (Chapter 37). Amendments to the Chapter 37 of the Common veterinary requirements were notified in G/SPS/N/RUS/36 (17 October 2013).These amendments precise that requirements on absence of botulinic toxin applied only for canned pet feed.

Products Covered: Common list of goods subject to veterinary control, adopted by the Customs Union (CU) Commission Decision on application of veterinary and sanitary measures in the CU as of 18 June 2010 No. 317

Regulation Type: Regular notification

Distribution date: 25 October 2013 | Final date for Comment: 24 December 2013

The Minimum Requirements for Biological Products is to be partially amended to add the standard for a vaccine product to be newly approved.

Products Covered: Drugs (HS: 30)

Regulation Type: Regular notification

Distribution date: 25 October 2013 | Final date for Comment: 24 December 2013

The Minimum Requirements for Biological Products is to be partially amended to add the standard for a vaccine product to be newly approved.

Products Covered: Drugs (HS: 30)

Regulation Type: Regular notification

Distribution date: 23 October 2013 | Final date for Comment: 22 December 2013

<p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>New draft regulations announced by Israel's Ministry of Health called "<em><span style="font-style:italic;">Pharmacists' Regulations (Cosmetics)</span></em>". This draft regulation fully adopts the European model for marketing of cosmetics outlined in "<em><span style="font-style:italic;">Regulation (EC) No. 1223/2009 of The European Parliament and of The Council of 30 November 2009 on Cosmetic Products</span></em>", which according to professionals provides the best basis for controlling the marketing of cosmetics, the lowering of trade barriers and safeguarding of consumers.</span></span></span></p><p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>The new regulations are significantly different from the way cosmetics had been controlled and supervised in Israel in the past. It does away with the supplier's need to obtain a registration certificate and requires only a notification 10 days prior to marketing. According to this change, the major responsibilities of the Ministry of Health will shift<span>&nbsp; </span>to formulation of the rules and regulations for cosmetic marketing in Israel and determination of the bodies and mechanisms<span>&nbsp; </span>authorized to manufacture and market cosmetics. All these will be accompanied by a strict market surveillance system.</span></span></span></p><p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>These are the major requirements introduced in the regulations: </span></span></span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">No person shall import into Israel a cosmetic unless the product has been granted a Certificate of Free Sale by a recognized country.</span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person who will be the legal entity responsible for the product and for the regulatory procedures governing it (regulation 5);</span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">In order to</span><span style="letter-spacing:-0.1pt;"> ensure their safety, cosmetic products placed on the market should be produced according to Good Manufacturing Practice</span><span lang="EN-US" style="letter-spacing:-0.1pt;"> (GMP) and distributors shall ensure that storage and transport conditions do not jeopardize their compliance with the requirements set out in these Regulations (regulations 8 and 11);</span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">Requires a safety assessment from a suitable professional that will cover all safety aspects of the cosmetic product, including its ingredients, side effects and required warnings (Regulation 12 and Annex 3);</span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">For the purpose of effective market surveillance, a product information file should be made readily accessible to the competent authority and should include information<span>&nbsp; </span>and data about the product, its safety assessment, manufacturing procedures, tests, claims against it, if served, and data on any animal testing performed (Regulation 13);</span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span style="font-size:small;"><span style="font-size:9.5pt;">Prior to placing the cosmetic product on the market, the responsible person shall provide<span>&nbsp; </span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">the Ministry of Health</span><span style="font-size:small;"><span lang="EN-US" style="font-size:9.5pt;"></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;"><span>&nbsp;</span>electronically the<span>&nbsp; </span>general information required for the basic control by the Director General of the Ministry of Health or his representative (Regulation 14);</span></p><span style="font-size:x-small;font-face:Verdana;"><span style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;">Establishment</span><span style="font-size:x-small;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;">of a National Cosmetics Poison Center which will hold full information about the cosmetic ingredients, including dosages, which may include confidential trade secrets that will be kept safe by the Ministry of Health. The information will be used only in case of an emergency for providing medical treatment to people affected by cosmetics (Regulation 26).</span></span></span>

Products Covered: Cosmetics (HS: Chapter 33; ICS: 71.100.70).

Regulation Type: Regular notification

Distribution date: 23 October 2013 | Final date for Comment: 22 December 2013

<p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>New draft regulations announced by Israel's Ministry of Health called "<em><span style="font-style:italic;">Pharmacists' Regulations (Cosmetics)</span></em>". This draft regulation fully adopts the European model for marketing of cosmetics outlined in "<em><span style="font-style:italic;">Regulation (EC) No. 1223/2009 of The European Parliament and of The Council of 30 November 2009 on Cosmetic Products</span></em>", which according to professionals provides the best basis for controlling the marketing of cosmetics, the lowering of trade barriers and safeguarding of consumers.</span></span></span></p><p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>The new regulations are significantly different from the way cosmetics had been controlled and supervised in Israel in the past. It does away with the supplier's need to obtain a registration certificate and requires only a notification 10 days prior to marketing. According to this change, the major responsibilities of the Ministry of Health will shift<span>&nbsp; </span>to formulation of the rules and regulations for cosmetic marketing in Israel and determination of the bodies and mechanisms<span>&nbsp; </span>authorized to manufacture and market cosmetics. All these will be accompanied by a strict market surveillance system.</span></span></span></p><p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>These are the major requirements introduced in the regulations: </span></span></span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">No person shall import into Israel a cosmetic unless the product has been granted a Certificate of Free Sale by a recognized country.</span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person who will be the legal entity responsible for the product and for the regulatory procedures governing it (regulation 5);</span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">In order to</span><span style="letter-spacing:-0.1pt;"> ensure their safety, cosmetic products placed on the market should be produced according to Good Manufacturing Practice</span><span lang="EN-US" style="letter-spacing:-0.1pt;"> (GMP) and distributors shall ensure that storage and transport conditions do not jeopardize their compliance with the requirements set out in these Regulations (regulations 8 and 11);</span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">Requires a safety assessment from a suitable professional that will cover all safety aspects of the cosmetic product, including its ingredients, side effects and required warnings (Regulation 12 and Annex 3);</span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">For the purpose of effective market surveillance, a product information file should be made readily accessible to the competent authority and should include information<span>&nbsp; </span>and data about the product, its safety assessment, manufacturing procedures, tests, claims against it, if served, and data on any animal testing performed (Regulation 13);</span></p><p style="margin:6pt 0cm 6pt 22.35pt;text-indent:-21.25pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;"><span>-<span style="font-size:x-small;font-face:Times New Roman;"><span style="font:7pt/normal 'Times New Roman';">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span></span></span></span><span style="font-size:small;"><span style="font-size:9.5pt;">Prior to placing the cosmetic product on the market, the responsible person shall provide<span>&nbsp; </span></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;">the Ministry of Health</span><span style="font-size:small;"><span lang="EN-US" style="font-size:9.5pt;"></span></span><span lang="EN-US" style="letter-spacing:-0.1pt;"><span>&nbsp;</span>electronically the<span>&nbsp; </span>general information required for the basic control by the Director General of the Ministry of Health or his representative (Regulation 14);</span></p><span style="font-size:x-small;font-face:Verdana;"><span style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;">Establishment</span><span style="font-size:x-small;"><span lang="EN-US" style="letter-spacing:-0.1pt;font-size:9pt;">of a National Cosmetics Poison Center which will hold full information about the cosmetic ingredients, including dosages, which may include confidential trade secrets that will be kept safe by the Ministry of Health. The information will be used only in case of an emergency for providing medical treatment to people affected by cosmetics (Regulation 26).</span></span></span>

Products Covered: Cosmetics (HS: Chapter 33; ICS: 71.100.70).

Regulation Type: Regular notification

Distribution date: 22 October 2013 | Final date for Comment: 21 December 2013

The document introduces amendments to CU legislation specifically to the CU Common list of goods subject to veterinary control. It adjusts the HS codes column with the column of description of the goods subject to veterinary control. The following HS codes "from 2852 10 000 2", "from 2852 10 000 8", "2852 90 000 2", "from 2852 90 000 4", "from 2852 90 000 7" are deleted from the column for HS codes of the CU Common list. It is technical correction.

Products Covered: Common list of goods subject to veterinary control, adopted by the Customs Union (CU) Commission Decision on application of veterinary and sanitary measures in the CU as of 18 June 2010 No. 317

Regulation Type: Regular notification

Distribution date: 22 October 2013 | Final date for Comment: 21 December 2013

The document introduces amendments to CU legislation specifically to the CU Common list of goods subject to veterinary control. It adjusts the HS codes column with the column of description of the goods subject to veterinary control. The following HS codes "from 2852 10 000 2", "from 2852 10 000 8", "2852 90 000 2", "from 2852 90 000 4", "from 2852 90 000 7" are deleted from the column for HS codes of the CU Common list. It is technical correction.

Products Covered: Common list of goods subject to veterinary control, adopted by the Customs Union (CU) Commission Decision on application of veterinary and sanitary measures in the CU as of 18 June 2010 No. 317

Regulation Type: Regular notification

Distribution date: 11 October 2013 | Final date for Comment: 10 December 2013

This draft technical regulation concerns specific characteristics of lavender oil to facilitate assessment of its quality.

Products Covered: Oil of lavender (Lavandula angustifolia Mill) (ICS Code: 71.100.60)

Regulation Type: Regular notification

Distribution date: 11 October 2013 | Final date for Comment: 10 December 2013

This draft technical regulation concerns specific characteristics of lavender oil to facilitate assessment of its quality.

Products Covered: Oil of lavender (Lavandula angustifolia Mill) (ICS Code: 71.100.60)

Regulation Type: Regular notification

Distribution date: 11 October 2013

This letter introduces a temporary restriction on import of milk and milk products from Lithuania to the Russian Federation due to detection of incompliance to microbiology, sanitary chemical and organoleptic requirements.

Products Covered: Milk and dairy products (HS Codes: 0401-0406)

Regulation Type: Emergency notifications (SPS)