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J4nt1,8GkV^!`e@'^*?#>A.2.gZ8AERCU2V*rXJhIOh]@FC2)JV(\ k[CpiOUCe^h?in!aT*V=*.LH"ZrIF>Z3K$3J^!E%cQo#65H!M[/BbHtlc;A>bbf OVM.0\m`:mITpsj#X%>8MJ,9mfeZp6]hkT6ar,et@u!DkPibBa(A.f$. endobj << stream stream #eCj'H0UD_\P>D^@lMe8'r/$C`^``re/X_+;*d/[W$8`E9]a'["J-&4SBj4U7^u0$ !NK203nk&+`18\P,/-1snY.2oGeEAo@QBk!JRT.f endobj ?7Y(eNY54]!_T+FfGE9(YB4^V>S$Dqna)[r"/ ]*U@1I=';95O>s.i%l@/bIjiJLd>HUl`.BuTT2>s%E3bUr_&(EOV*m(d'Fk#5[QOEF(m^1 ".0=Ml!SqQ /GS1 8 0 R /ExtGState << << /ProcSet [/PDF /Text ] ;:P/\fJZGt`>`tLF=*6q1.^;uLb/0l&>s:AOFhW)*AcE@([b_n' ANNEX I. [-#BhtJI)h8BM:hZUm_sk Article 2 U.K.. Commission communication 2017/C 389/04 is repealed. /GS1 8 0 R 50 0 obj /F9 5 0 R << 'C[p* stream . 3/;05BnZdbQ;mE_RF^0u=A)W#HP4+#s*BA=on(;i#6-`Z?d]`#1.V;s)j9BX4P=C( /F10 6 0 R [H9;2*in(Tkg7@'Ls-IiD>Re=9S:d;]sQTXF,$7SOTi=%B==PG\[`PK?4ZFA^*(e)_NYXussAeX8JEDeluY9+N@?Vh7\"/)f;8 8;XEL968iI'#(D=rrGW$94mrG[C9tlR7_4+pCPk]Z? @iqrn35L#%V$+#DCd7G!cSrL[-0iJ0Q,GW4%'c+9=+Hq! 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