Distribution date: 06 June 2003 | Final date for Comment: 19 April 2025

The Thai Industrial Standards Institute (TISI) has proposed to revise a mandatory standard TIS 531-2536(1993) Plastics Containers for Sterile Pharmaceutical Products. This standard classifies plastics containers based on materials used into four types, i.e. polyethylene, polypropylene, polyvinyl chloride and composite plastic. Specifies materials property, requirements for workmanship, physical, chemical and biological characteristics (e.g. capacity, uniformity of thickness, leakage, drop impact resistance, pressure resistance, flexibility, permeability to water vapour, residue on ignition, fine particles content, translucent, safety requirements for extracted solution, calcium content, heavy metals content, vinyl chloride monomer content and biological requirements). Includes marking, labelling, sampling and criteria for conformity and testing.

Products Covered: Medicaments (HS Chapter 9018.90, ICS:  11.120.10)

Regulation Type: Regular notification

Distribution date: 13 June 2003 | Final date for Comment: 19 April 2025

In notification G/SPS/N/EEC/72 (16 April 1999) the EC informed of a proposal ending in: Regulation 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies. (OJ. L147, 31/05/2001, pp:1-40). This regulation lays down certain trade conditions as transitional measures, which in particular relate to the absence of specified BSE risk material in products exported to the EU. Countries where the BSE presence in the cattle population is considered highly unlikely are exempted from these trade conditions and are listed in point 10 of Annex XI to this Regulation including Costa Rica. In its opinion on 11 January 2002, the Scientific Steering Committee adopted an opinion to update the method to establish the geographical BSE risk. When assessing the external challenge it was agreed not only to take into account the imports from countries where BSE had been confirmed but also the imports from other countries with a BSE risk (GBR III) but no confirmed cases. Countries, which were assessed under the old method, should therefore be reassessed. This opinion is available in http://europa.eu.int/comm/food/fs/sc/ssc/out243_en.pdf In its updated opinion of 10 April 2003 on the geographical BSE risk of certain third countries, the SSC modified the previous opinion on Costa Rica and concluded that the occurrence of BSE in native cattle in Costa Rica is unlikely but not excluded. This opinion is available fromhttp://europa.eu.int/comm/food/fs/sc/ssc/out333_en.pdf The original rationale for exempting Costa Rica from the import conditions is consequently no longer valid, and therefore it is proposed to delete Costa Rica from the list of exempted countries.

Products Covered: Meat of bovine animals, fresh or chilled (0201), Meat of bovine animals, frozen (0202), Meat of sheep or goats, fresh, chilled or frozen (0204), Edible offal of bovine animals fresh, chilled or frozen (0206), Meat of bovine animals and edible meat offal, salted, in brine, dried or smoked; edible flours and meals of meat or meat offal (0210 20), Guts, bladders and stomachs of animals (other than fish), whole and pieces thereof, fresh, chilled frozen, salted, in brine, dried or smoked (0504), Raw material for the manufacture of animal feedingstuffs (CN 0210.90). Bones and horn-cores, unworked, defatted, simply prepared (but not cut to shape), treated with acid or degelatinised; powder and waste of these products (0506), Fats of bovine animals, sheep or goats, other than those of heading 1503 (1502), Sausages and similar products, of meat, meat offal or blood; food preparations based on these products (1601), Other prepared or preserved meat, meat offal or blood (1602), Flours, meals and pellets, of meat or meat offal, of fish or of crustaceans, molluscs or other aquatic invertebrates, unfit for human consumption; greaves (2301), Gelatine (including gelatin in rectangular (including square) sheets, whether or not surface-worked or coloured) and gelatine derivatives; isinglass; other glues of animal origin, excluding casein glues of heading 3501 (3503).

Regulation Type: Regular notification

Distribution date: 13 June 2003 | Final date for Comment: 19 April 2025

In notification G/SPS/N/EEC/72 (16 April 1999) the EC informed of a proposal ending in: Regulation 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies. (OJ. L147, 31/05/2001, pp:1-40). This regulation lays down certain trade conditions as transitional measures, which in particular relate to the absence of specified BSE risk material in products exported to the EU. Countries where the BSE presence in the cattle population is considered highly unlikely are exempted from these trade conditions and are listed in point 10 of Annex XI to this Regulation including Costa Rica. In its opinion on 11 January 2002, the Scientific Steering Committee adopted an opinion to update the method to establish the geographical BSE risk. When assessing the external challenge it was agreed not only to take into account the imports from countries where BSE had been confirmed but also the imports from other countries with a BSE risk (GBR III) but no confirmed cases. Countries, which were assessed under the old method, should therefore be reassessed. This opinion is available in http://europa.eu.int/comm/food/fs/sc/ssc/out243_en.pdf In its updated opinion of 10 April 2003 on the geographical BSE risk of certain third countries, the SSC modified the previous opinion on Costa Rica and concluded that the occurrence of BSE in native cattle in Costa Rica is unlikely but not excluded. This opinion is available fromhttp://europa.eu.int/comm/food/fs/sc/ssc/out333_en.pdf The original rationale for exempting Costa Rica from the import conditions is consequently no longer valid, and therefore it is proposed to delete Costa Rica from the list of exempted countries.

Products Covered: Meat of bovine animals, fresh or chilled (0201), Meat of bovine animals, frozen (0202), Meat of sheep or goats, fresh, chilled or frozen (0204), Edible offal of bovine animals fresh, chilled or frozen (0206), Meat of bovine animals and edible meat offal, salted, in brine, dried or smoked; edible flours and meals of meat or meat offal (0210 20), Guts, bladders and stomachs of animals (other than fish), whole and pieces thereof, fresh, chilled frozen, salted, in brine, dried or smoked (0504), Raw material for the manufacture of animal feedingstuffs (CN 0210.90). Bones and horn-cores, unworked, defatted, simply prepared (but not cut to shape), treated with acid or degelatinised; powder and waste of these products (0506), Fats of bovine animals, sheep or goats, other than those of heading 1503 (1502), Sausages and similar products, of meat, meat offal or blood; food preparations based on these products (1601), Other prepared or preserved meat, meat offal or blood (1602), Flours, meals and pellets, of meat or meat offal, of fish or of crustaceans, molluscs or other aquatic invertebrates, unfit for human consumption; greaves (2301), Gelatine (including gelatin in rectangular (including square) sheets, whether or not surface-worked or coloured) and gelatine derivatives; isinglass; other glues of animal origin, excluding casein glues of heading 3501 (3503).

Regulation Type: Regular notification

Distribution date: 13 June 2003 | Final date for Comment: 19 April 2025

Updates the requirements for importing blood meal, haemoglobin and powdered plasma into Chile and repeals Resolution No. 810 of 1996.

Products Covered: Blood meal, haemoglobin and powdered plasma.

Regulation Type: Regular notification

Distribution date: 13 June 2003 | Final date for Comment: 19 April 2025

Updates the requirements for importing blood meal, haemoglobin and powdered plasma into Chile and repeals Resolution No. 810 of 1996.

Products Covered: Blood meal, haemoglobin and powdered plasma.

Regulation Type: Regular notification

Distribution date: 16 June 2003 | Final date for Comment: 19 April 2025

Revision of maximum residue limits for quinoxaline-2-carboxylic acid (QCA) in pig muscle and liver

Products Covered: Pig muscle and pig liver

Regulation Type: Regular notification

Distribution date: 16 June 2003 | Final date for Comment: 19 April 2025

The legal instrument used to revoke the import health standard for foetal bovine serum, calf serum and bovine serum for further processing into New Zealand from Canada (dated 12 March 2001).

Products Covered: Filtered and irradiated foetal bovine serum, calf serum and bovine serum

Regulation Type: Emergency notifications (SPS)

Distribution date: 16 June 2003 | Final date for Comment: 19 April 2025

Revision of maximum residue limits for quinoxaline-2-carboxylic acid (QCA) in pig muscle and liver

Products Covered: Pig muscle and pig liver

Regulation Type: Regular notification

Distribution date: 16 June 2003 | Final date for Comment: 19 April 2025

The legal instrument used to revoke the import health standard for foetal bovine serum, calf serum and bovine serum for further processing into New Zealand from Canada (dated 12 March 2001).

Products Covered: Foetal bovine serum, calf serum and bovine serum

Regulation Type: Emergency notifications (SPS)

Distribution date: 16 June 2003 | Final date for Comment: 19 April 2025

The legal instrument used to revoke the import health standard for foetal bovine serum, calf serum and bovine serum for further processing into New Zealand from Canada (dated 12 March 2001).

Products Covered: Foetal bovine serum, calf serum and bovine serum

Regulation Type: Emergency notifications (SPS)