Chile Consults Over Rules for Food Contact Materials

SafeGuardSHardgoodsAug 13, 2025

SG 117/25

Chile is planning to strengthen the nation’s requirements for food contact materials (FCMs) and articles.

On July 25, 2025, Chile’s Ministry of Health (Ministerio de Salud, MINSAL) initiated a public consultation on its proposal to replace Title XXX under the nation’s Food Sanitary Regulations (Decree 977/96) with general and specific requirements for FCMs and articles:

These modifications are based on legislation in the European Union (EU) and guidelines from the Southern Common Market (Mercado Común del Sur, Mercosur), with the aim to further improve human health by establishing general and specific requirements for FCMs and articles beyond the current general safety requirements under Decree 977/96, Title II, Paragraph III, Articles 122-129.

Key highlights of the proposal are summarized in Table 1.

Section to Title XXX ‘Materials and articles in contact with food’	Highlight
Paragraph I ‘FCMs and articles’	Exempts coating or lining materials, such as the materials covering cheese rinds, meat products or fruits, which form part of the food as they may be consumed together Introduces several terms and their definitions, including 1) good manufacturing practice (GMP), 2) marketing of FCMs and articles, 3) packaging, 4) wrapping, 5) equipment, 6) FCMs and articles, 7) active and intelligent materials and articles, 8) containers, 9) coating, 10) traceability and 11) utensils Requires FCMs and articles to comply with GMP, and they must not transfer their constituents to food in a manner that could endanger human health, cause an unacceptable change in food composition, or bring about a deterioration in the organoleptic characteristics of food Defines specifications for metals and their raw materials: ≤ 1% sum of antimony, chromium, copper, iron, lead, tin and zinc ≤ 0.01% arsenic or other harmful metal or metalloid contaminants (cf. Article 125 to Decree 977/96) Directs the establishment of a traceability system in order to facilitate control, the recall of non-compliant products, consumer information and attribution of responsibility Mandates a declaration of conformity (DoC) for compliant products in the supply chain, except those sold to the final consumer Requires FCMs and articles, which are not yet in contact with food when placed on the market, to be accompanied by the term ‘for food contact’, or a specific indication of their use, or the ‘glass and fork’ symbol This provision is not mandatory for FCMs and articles, such as crockery, cutlery and salt shakers, that are clearly intended to come into contact with food Requires printing inks on the non-food contact side of FCMs and articles to be formulated and/or applied in a manner that ensures substances from the printed surfaces are not transferred to the food-contact side that will affect their general safety Prohibits printed surfaces from coming into direct contact with food
Paragraph III ‘Food contact plastics’	Establishes several terms and their definitions, including but not limited to 1) additives, 2) overall migration limit (OML), 3) specific migration limit (SML), 4) total SML (TSML), 5) hot-filling, 6) food simulant and 7) non-intentionally added substances (NIAS) Exempts adhesives and inks, but they must comply with general safety provisions Excludes ion exchange resins, rubber and silicones from the scope of plastics Directs the Ministry of Health to determine the following by means of a Technical Standard: 'Positive list of substances that can be used to manufacture plastic materials in direct contact with food’ – contains more than 1,000 substances with specifications and restrictions, including but not limited to phthalates: 1) DBP (FCM substance no 157), 2) BBP (159), 3) DEHP (283), 4) diallyl phthalate (316), 5) DINP (728) and DIDP (729) Detailed specifications on substances ‘Restrictions for group substances’ ‘Notes on verification of compliance’ ‘Specific migration limits for BADGE and some of its derivatives’, including a ban on BFDGE and other NOGE 'Restrictions applicable to plastic materials and articles’ - contains specifications for 24 elements, of which 19 have an SML and restriction of primary aromatic amines (PAA) ‘Food simulants’ - includes ‘General assignment of food simulants to food’ and ‘Specific assignment of food simulants to foods for migration testing from materials and articles not yet in contact with food’ Requires documentation, which must include test reports, for demonstrating compliance to be made available when requested by the authorities ≤ 0.01 mg/kg for substances without an SML on the positive list Permits NIAS and polymerization aids not on the positive list, provided they are not carcinogenic, mutagenic or reprotoxic (CMR) substances ≤ 10 mg/dm² overall migration (OM), otherwise ≤ 60 mg/kg OM for food for infants and young children under paragraphs II to IV of Title XXVIII ‘Foods for special diets’ under Decree 977/96 ≤ 0.01 mg/kg for specific migration (SM) of substances, or groups of substances, that are not on the positive list Permits demonstration of compliance by test reports from non-domestic laboratories accredited in their respective countries, or certifications issued by accredited certification bodies in their respective countries or, in addition, by a written declaration by the manufacturer/importer that allows identification of the materials, articles, products of intermediate manufacturing stages and indicates compliance with this regulation Permits the use of recycled plastics, provided they comply with this regulation and that their plants must have a favorable ‘health report’ from the regional Ministry of Health

Section to Title XXX ‘Materials and articles in contact with food’

Highlight

Paragraph I
‘FCMs and articles’

Exempts coating or lining materials, such as the materials covering cheese rinds, meat products or fruits, which form part of the food as they may be consumed together
Introduces several terms and their definitions, including 1) good manufacturing practice (GMP), 2) marketing of FCMs and articles, 3) packaging, 4) wrapping, 5) equipment, 6) FCMs and articles, 7) active and intelligent materials and articles, 8) containers, 9) coating, 10) traceability and 11) utensils
Requires FCMs and articles to comply with GMP, and they must not transfer their constituents to food in a manner that could endanger human health, cause an unacceptable change in food composition, or bring about a deterioration in the organoleptic characteristics of food
Defines specifications for metals and their raw materials:

≤ 1% sum of antimony, chromium, copper, iron, lead, tin and zinc
≤ 0.01% arsenic or other harmful metal or metalloid contaminants (cf. Article 125 to Decree 977/96)

Directs the establishment of a traceability system in order to facilitate control, the recall of non-compliant products, consumer information and attribution of responsibility
Mandates a declaration of conformity (DoC) for compliant products in the supply chain, except those sold to the final consumer
Requires FCMs and articles, which are not yet in contact with food when placed on the market, to be accompanied by the term ‘for food contact’, or a specific indication of their use, or the ‘glass and fork’ symbol

This provision is not mandatory for FCMs and articles, such as crockery, cutlery and salt shakers, that are clearly intended to come into contact with food

Requires printing inks on the non-food contact side of FCMs and articles to be formulated and/or applied in a manner that ensures substances from the printed surfaces are not transferred to the food-contact side that will affect their general safety
Prohibits printed surfaces from coming into direct contact with food

Paragraph III
‘Food contact plastics’

Establishes several terms and their definitions, including but not limited to 1) additives, 2) overall migration limit (OML), 3) specific migration limit (SML), 4) total SML (TSML), 5) hot-filling, 6) food simulant and 7) non-intentionally added substances (NIAS)
Exempts adhesives and inks, but they must comply with general safety provisions
Excludes ion exchange resins, rubber and silicones from the scope of plastics
Directs the Ministry of Health to determine the following by means of a Technical Standard:

'Positive list of substances that can be used to manufacture plastic materials in direct contact with food’ – contains more than 1,000 substances with specifications and restrictions, including but not limited to phthalates: 1) DBP (FCM substance no 157), 2) BBP (159), 3) DEHP (283), 4) diallyl phthalate (316), 5) DINP (728) and DIDP (729)
Detailed specifications on substances
‘Restrictions for group substances’
‘Notes on verification of compliance’
‘Specific migration limits for BADGE and some of its derivatives’, including a ban on BFDGE and other NOGE
'Restrictions applicable to plastic materials and articles’ - contains specifications for 24 elements, of which 19 have an SML and restriction of primary aromatic amines (PAA)
‘Food simulants’ - includes ‘General assignment of food simulants to food’ and ‘Specific assignment of food simulants to foods for migration testing from materials and articles not yet in contact with food’

Requires documentation, which must include test reports, for demonstrating compliance to be made available when requested by the authorities
≤ 0.01 mg/kg for substances without an SML on the positive list
Permits NIAS and polymerization aids not on the positive list, provided they are not carcinogenic, mutagenic or reprotoxic (CMR) substances
≤ 10 mg/dm² overall migration (OM), otherwise ≤ 60 mg/kg OM for food for infants and young children under paragraphs II to IV of Title XXVIII ‘Foods for special diets’ under Decree 977/96
≤ 0.01 mg/kg for specific migration (SM) of substances, or groups of substances, that are not on the positive list
Permits demonstration of compliance by test reports from non-domestic laboratories accredited in their respective countries, or certifications issued by accredited certification bodies in their respective countries or, in addition, by a written declaration by the manufacturer/importer that allows identification of the materials, articles, products of intermediate manufacturing stages and indicates compliance with this regulation
Permits the use of recycled plastics, provided they comply with this regulation and that their plants must have a favorable ‘health report’ from the regional Ministry of Health

Table 1

According to the proposal, the date of entry into force (EIF) after its publication in the Official Gazette is:

24 months for OMs
48 months for SMs and total SMs

FCMs and articles may comply in accordance with this modification from the date of its publication in the Official Gazette.

Comments on the proposal will be accepted until September 23, 2025.

Abbreviations

Entry	Abbreviation	Chemical Name	CAS
1	BADGE	2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether	1675-54-3
2	BBP	Phthalic acid, benzyl butyl ester	85-68-7
3	BFDGE	bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers	39817-09-9
4	DBP	Phthalic acid, dibutyl ester	84-74-2
5	DEHP	Phthalic acid, bis(2-ethylhexyl) ester	117-81-7
6	DIDP	Phthalic acid, diesters with primary, saturated C₉-C₁₁ alcohols more than 90 % C₁₀	68515-49-1 26761-40-0
7	DINP	Phthalic acid, diesters with primary, saturated C₈-C₁₀ branched alcohols, more than 60 % C₉	68515-48-0 28553-12-0
8	NOGE	Novolac glycidyl ethers	---

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